GENOPTIX DELIVERS CLEAR, COMPREHENSIVE, AND CLINICALLY ACTIONABLE RESULTS

Transcription

1 TESTING DIRECTORY APRIL 2017

2 GENOPTIX DELIVERS CLEAR, COMPREHENSIVE, AND CLINICALLY ACTIONABLE RESULTS Genoptix Medical Laboratory 2110 Rutherford Road Carlsbad, CA Phone: Fax: Client Services Phone: Fax: ONCOLOGY EXPERTISE At Genoptix, we specialize in oncology diagnostics and informatics services. As one of the largest hematopathology centers in the U.S., we provide community oncologists and pathologists with comprehensive testing solutions in hematology and solid tumor molecular profiling. With reliable and clinically actionable reports, we empower clinicians to make more informed decisions and provide better patient care. CLIA No: 05D CAP LAP No: CA Clinical Lab License No: CLF Medical Director: Derek Lyle, MD genoptix.com

3 GENOPTIX TESTING DIRECTORY APRIL 2017 TABLE OF CONTENTS HIPAA Patient Privacy, Confidentiality, and HIPAA Information... 1 BILLING CODES CPT Codes... 1 MolDx Z Codes CONSULTATIVE SERVICES COMPASS Blood Evaluation...5 COMPASS Bone Marrow Evaluation...5 COMPASS Select without Morphology...6 COMPASS Select without Flow....6 COMPASS Select without Cytogenetics...7 CHART...8 Second Opinion Consultation....9 SUMMARY REPORT NexCourse...9 HOURS OF OPERATION Our lab is open six days a week: 5:00am to 7:00pm PT Mon-Fri 7:00am to 3:30pm PT Saturday For after-hours assistance, your call will be connected with an on-duty Client Services Representative. NGS PROFILES (SMALL & MIGHTY) AML Molecular Profile...26 CLL Targeted Profile Lymphoid Molecular Profile MPN Targeted Profile...35 Myeloid Molecular Profile...35 CNS Molecular Profile...48 CRC Targeted Profile...49 Lung Targeted Profile Melanoma Targeted Profile...52 HEMATOLOGY PATHOLOGY/MORPHOLOGY Blood Morphology...11 Bone Marrow Morphology CYTOGENETICS Chromosome Analysis...12 FISH ALL FISH Profile AML FISH Profile...14 CLL FISH Profile...14 CML FISH Profile...15 ifish Profile...15

4 TABLE OF CONTENTS MDS FISH Profile (Standard)...16 MDS FISH Profile (Extended) MPN - Eosinophilia FISH Profile MPN FISH Profile Myeloma FISH Profile NHL FISH Profile...18 UroVysion...19 FLOW CYTOMETRY Intelligent Flow Profile (Blood or Bone Marrow)...20 Intelligent Flow Profile (Fresh Tissue)...20 Acute Leukemia Panel (Add-on) B-ALL MRD Profile...21 B-Cell Clonality (Add-on)...22 CLL MRD Profile...22 LGL Panel (Add-on)...23 Mature B-Cell Panel (Add-on)...23 Myeloma MRD Profile Myeloma Panel (Add-on)...24 PNH Evaluation...25 MOLECULAR ABL1 Kinase Domain Mutation...26 AML Molecular Profile...26 B-Cell Clonality Assessment...27 CALR Mutation Analysis CLL Comprehensive Profile...28 CLL Targeted Profile KIT (D816V) Mutation Analysis FLT3 Mutation Analysis ITD/TKD...30 FLT3/NPM1 Mutation Analysis...30 GenoTRACE Quantitative BCR-ABL...31 IgVH Hypermutation Analysis...31 JAK2 Exon 12/ JAK2 V617F Mutation Analysis...32 Lymphoid Molecular Profile MLL-PTD Mutation Analysis MPL Mutation Analysis...34 MPN Targeted Profile...35 Myeloid Molecular Profile...35 T-Cell Clonality Assessment (Beta) T-Cell Clonality Assessment (Gamma) SOLID TUMOR CYTOGENETICS ALK Rearrangement...39 FGFR1 Amplification...39 HER2 Amplification...40 MET Amplification...40 RET Rearrangement...41 ROS1 Rearrangement...41 IMMUNOHISTOCHEMISTRY (IHC) IHC Antibodies and Special Stains...42 Breast Image Analysis...44 Estrogen Receptor (ER)...45 Progesterone Receptor (PR) PD-L1 IHC 22C HER Ki MOLECULAR BRAF V600E Mutation Analysis for non-melanoma (LDT)...48 CNS Molecular Profile...48 CRC Targeted Profile...49 EGFR Mutation Analysis KRAS Mutation Analysis (FDA) for Colorectal Cancer KRAS Mutation Analysis (LDT) for non-colorectal Cancer Lung Targeted Profile Melanoma Targeted Profile...52 MSI Analysis...52 NexCourse Complete...53 THxID BRAF Mutation Analysis for Melanoma....54

5 GENOPTIX TESTING DIRECTORY PATIENT PRIVACY, CONFIDENTIALITY, AND HIPAA INFORMATION Genoptix Medical Laboratory is committed to protecting the privacy and security of protected health information (PHI) in our possession, and to complying with all state and federal requirements applicable to the handling and release of medical records and medical information. As a provider of health care services, Genoptix is considered a covered entity under the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Genoptix has developed and implemented certain policies and procedures to ensure its compliance with applicable HIPAA rules and regulations, including those pertaining to Privacy, Security, and Transaction and Code Set Standards. In accordance with the HIPAA Privacy Regulation (45 CFR ), the use and disclosure of PHI without a specific patient authorization is permitted in order to carry out treatment, payment, or health care operations. The Health Information Technology for Economic and Clinical Health (HITECH) Act is part of the American Recovery and Reinvestment Act (ARRA) of 2009 and amended HIPAA in several respects. Genoptix complies with additional requirements mandated by this law which includes additional notification requirements for breaches of unsecured PHI. Should you have questions regarding Genoptix privacy or confidentiality provisions, please contact us at CPT CODES CPT Codes included in this publication are in accordance with Current Procedural Terminology, a publication of the American Medical Association. CPT Codes are provided here for the convenience of our clients only. Multiple units of service may be billed for CPT Codes, and all CPT Codes are subject to change. These codes reflect our interpretation of the code descriptions and their application to our testing procedures. Additionally, when testing is performed in combination with other assays, CPT Code frequencies may decrease. Because coding accuracy is the responsibility of the billing entity, we request that you reaffirm the appropriateness of these codes by referencing to the most current version of the CPT Coding Manual of the American Medical Association (AMA) at or by visiting the Centers for Medicare and Medicaid Services (CMS) web site at: MOLDX Z CODES The Molecular Diagnostic Services Program (MolDX), launched in 2011, is administered by Palmetto GBA for the Centers for Medicare & Medicaid Services. Its policies are also followed by two other Medicare Administrative Contractors Noridian (JE and JF Regions) and CGS (J15 Region). Under the MolDX Program, Palmetto GBA requires all labs to obtain a Z-Code Identifier through the McKesson Diagnostics Exchange for each molecular diagnostic test. A Z-Code Identifier is a unique 5-character alpha-numeric associated with a specific diagnostic test, enabling the consistent identification of the test across systems by labs, providers, payers and policy-makers. CPT codes remain as the process codes for billing, while Z-Codes offer Palmetto GBA a way to track test utilization with greater granularity than the current coding system allows. The MolDX Program currently covers JE (CA, NV, HI), JF (WA, OR, ID, MT, WY, AZ, ND, SD, UT, Aleutian Islands), JM (NC, SC, VA, WV), J15 (TN, OH), J5 (IA, MO, KS, NE) and J8 (MI, IN). Labs that perform services for patients in those states, must register in order to submit a Medicare claim. 1

6 Medicare and other third party payors require that services be medically necessary for coverage. Medicare generally does not cover routine screening tests. *See reverse for a list of genes in each profile. **A second opinion consultation will be issued when submitted records include first opinion/diagnosis/microscopic impression. A first opinion pathologist microscopic interpretation may be reported and billed instead, depending on the records provided. 1 LAB COPY 2 CLIENT COPY APRIL 2017 RQ Medicare and other third party payors require that services be medically necessary for coverage. Medicare generally does not cover routine screening tests. All testing includes interpretation and all solid tumor tissues feature Pathologist Directed Analysis. If more than one test is ordered, a summary report will be issued. Pathologist Directed Analysis: Cancer-rich regions are identified by a pathologist and microdissected, when indicated, prior to testing for added sensitivity and confidence in test results. 1 LAB COPY 2 CLIENT COPY APRIL 2017 SLDRQ Medicare and other third party payors require that services be medically necessary for coverage. Medicare generally does not cover routine screening tests. 1 LAB COPY 2 CLIENT COPY APRIL 2017 MDRQ GENOPTIX MAKES IT EASY Easy to Order Order testing online or complete the test requisition form. Include the patient insurance information and the appropriate clinical data. Retain a copy for your records. For ambiguous or missing test order information, we will contact the ordering physician to clarify the order before performing the test. Schedule Your Pickup To schedule a specimen pickup, call Genoptix at If you have a Genoptix Online (GO) user account, log on to go.genoptix.com. Request a pickup as part of your online order or select Tools > Request Pickup. Billing Questions? If you have any questions regarding your bill, please call Genoptix Billing at or billing@genoptix.com. HEMATOLOGY REQUISITION 2110 Rutherford Road Carlsbad, CA Client Services & Specimen Pick Up Fax SOLID TUMOR REQUISITION 2110 Rutherford Road Carlsbad, CA Client Services & Specimen Pick Up Fax GENOMIC PROFILING REQUISITION 2110 Rutherford Road Carlsbad, CA Client Services & Specimen Pick Up Fax HIGHLIGHTED FIELDS ARE REQUIRED INFORMATION. CLIENT INFORMATION PATIENT INFORMATION Account # Last Name First Name Account Name Patient SSN DOB Sex: M F Address Phone # Street City/State/Zip MRN/PT # Ordering Physician COG Patient Treating/Rendering Physician SPECIMEN/CLINICAL INFORMATION Phone # NPI Clinical information including patient history and recent CBC should be provided. Authorized Signature Date ICD-10 Code(s) BILLING INFORMATION Please attach a copy of the patient s insurance card. Collection date (mm/dd/yy) Time Bill to: Insurance Medicare Patient My Account (Hospital/Client) Specimen ID# Body site Patient Status: Hospital Inpatient Hospital Outpatient Non-hospital patient Specimen Source (Please select one) Hospital Discharge Date (if hospital in/outpatient) Bone Marrow: Green top(s) Purple top(s) Core Clot Authorization/Referral # Peripheral Blood: Green top(s) Purple top(s) Other Healthplan Name/IPA Smears: PB BM Touch preps Medicare/Policy # Group Plan # Slides: Stained Unstained Paraffin Block(s) Other: Fluid Tissue Type: Claims Address Name of Insured Ins Phone Diagnosis under consideration Relationship to insured: Self Spouse Child Other Clinical History Secondary Insurance: No Yes (If yes, please attach) Prior therapy: No Yes, details VI. This is a staging for lymphoma. Subtype I would like a Genoptix Hematopathologist to call me to discuss the case. Preferred phone number: SERVICE OPTIONS (SELECT ONE) I want Genoptix to request the specimen. (COMPLETE the information below.) Specimen enclosed. (Refer to back of requisition for specimen requirements.) LOCATION OF TISSUE SPECIMEN SPECIMEN ID ARCHIVE RETRIEVAL DATE PHONE FAX COMPASS COMPREHENSIVE ASSESSMENT INDIVIDUAL TECHNOLOGIES Includes COMPASS Consultation Report, clinical pathology evaluation, bone marrow and/or blood morphology (Up to I. Bone Marrow/Blood Morphology (Up to 20 stains and/or antibodies) 20 stains and/or antibodies), flow cytometry (Up to 40 antibodies), cytogenetics and/or FISH (Up to 14 probes), and II. Flow Cytometry (Up to 40 antibodies) molecular testing as medically necessary; a consultative review and correlation with all prior findings is performed by a Genoptix hematopathologist (when appropriate). Intelligent Flow Profile PNH Evaluation When serial or subsequent COMPASS Bone Marrow or Blood Evaluations are requested on the same patient and deemed B-ALL MRD (Previously treated ALL patients) Myeloma MRD (Previously treated clinically appropriate by a Genoptix hematopathologist, Genoptix will automatically provide a CHART (Comprehensive CLL MRD (Previously treated CLL patients) Myeloma patients) Hematopathology Assessment and Review over Time) Report, unless otherwise indicated by the ordering physician. III. Chromosome Analysis/FISH CHART includes all medically necessary technologies, and a consultative review and correlation with relevant prior findings by a Genoptix hematopathologist. Chromosome analysis and FISH as medically necessary (Up to 14 probes) Chromosome analysis (Only) COMPASS Evaluation FISH as medically necessary (Up to 14 probes) If medically appropriate, perform applicable NGS profile (Myeloid and Lymphoid FISH (Indicate desired probe[s] or profile in the Notes Section) disorders only; includes interpretation). IV. Molecular Tests (Includes interpretation) Test Information: Based on medical necessity, Genoptix hematopathologists will select the necessary special stains, GenoTRACE Quantitative BCR-ABL MPL Mutation Analysis antibodies, FISH probe(s), or molecular tests. You will be provided with a diagnosis from the technologies performed, ABL1 Kinase Mutation Analysis lgvh Hypermutation Analysis including morphologic evaluation where appropriate. CALR Mutation Analysis FLT3/NPM1 Mutation Analysis JAK2 Exon 12/13 FLT3 Mutation Analysis T-Cell Clonality Assessment Beta Gamma KIT (D816V) Mutation Analysis B-Cell Clonality Assessment PML/RARA Quantitative Analysis JAK2 V617F Mutation Analysis MLL-PTD Mutation Analysis If JAK2 V617F is negative, perform MPN Targeted Profile 5 genes* If JAK2 V617F is negative, perform CALR MPL JAK2 Exon V. Next-Gen Sequencing (Includes interpretation) Myeloid Molecular Profile 44 genes* Lymphoid Molecular Profile 128 genes* NOTES: MPN Targeted Profile 5 genes* CLL Comprehensive Profile 48 genes* CLL Targeted Profile 5 genes* NexCourse Complete 236 genes* AML Molecular Profile 24 genes* FOR LAB USE ONLY Second Opinion Consultation** Initial Impression: HIGHLIGHTED FIELDS ARE REQUIRED INFORMATION. CLIENT INFORMATION PATIENT INFORMATION Account # Last Name Account Name First Name Address Patient Social Security # Phone # Ordering Physician DOB Sex: Male Female MRN/PT # Treating/Rendering Physician Street Phone # NPI City State Zip Authorized Signature Date SPECIMEN/CLINICAL INFORMATION BILLING INFORMATION Clinical information including patient history and recent pathology report(s) should be provided. Please attach a copy of the patient s insurance card. ICD-10 Code(s) Bill to: Insurance Medicare Patient My Account (Hospital/Client) Patient Status: Hospital inpatient Hospital outpatient Non-hospital patient Collection date (mm/dd/yy) Time Hospital Discharge Date (if hospital in/outpatient) Primary Tumor Type Authorization/Referral # Specimen ID# Body site Healthplan Name/IPA Specimen Source (Please select one) Medicare/Policy # Group Plan # Peripheral Blood: Green top(s) Purple top(s) Other Claims Address Slides: Stained Unstained Paraffin Block(s) Name of Insured Ins Phone Other: Fluid Tissue Type: Relationship to insured: Self Spouse Child Other Secondary Insurance: No Yes (If yes, please attach) Diagnosis under consideration Clinical History Prior therapy: No Yes, details SERVICE OPTIONS (SELECT ONE) I want Genoptix to request the specimen. (COMPLETE the information below.) Specimen enclosed. (Refer to back of requisition for specimen requirements.) LOCATION OF TISSUE SPECIMEN SPECIMEN ID ARCHIVE RETRIEVAL DATE PHONE FAX If specimen quantity and/or quality is not sufficient for NGS, Genoptix pathologist will direct PCR, FISH and IHC testing as medically appropriate. Do not run PCR, FISH or IHC assays instead of NGS. I. NEXCOURSE FOR SOLID TUMORS LUNG (NSCLC) BREAST CANCER All Markers* ER, PR, HER2, Ki-67 (IHC) (No recurrence risk score) Individual Tests (See reverse for specimen instructions) IHC (Global) ER PR HER2 Ki-67 HER2 (IHC) reflex to FISH if IHC is equivocal HER2 (FISH) COLORECTAL (CRC) CRC Targeted Profile 3 genes (BRAF, KRAS, NRAS) by Next-Gen Sequencing plus MSI Analysis by PCR Individual Tests (See reverse for specimen instructions) CRC Targeted Profile (NGS) 3 genes (BRAF, KRAS, NRAS) MSI Analysis (PCR) KRAS Mutation Analysis (PCR) BRAF V600 Mutation Analysis (PCR) NOTES: Lung Targeted Profile (NGS) 7 genes** plus ALK, ROS1 and RET by FISH and PD-L1 22C3 by IHC Individual Tests (See reverse for specimen instructions) Lung Targeted Profile (NGS) 7 genes** PD-L1 22C3 (IHC) EGFR Mutation Analysis (PCR) ALK (FISH) ROS1 (FISH) RET (FISH) MET (FISH) BRAF V600 Mutation Analysis (PCR) KRAS Mutation Analysis (PCR) FGFR1 (FISH) MELANOMA Individual Tests (See reverse for specimen instructions) Melanoma Targeted Profile (NGS) 8 genes** THxID BRAF Mutation Analysis (PCR) II. NEXT GENERATION SEQUENCING BY CAPTURE-BASED TECHNOLOGY (Includes interpretation) CRC Targeted Profile 3 genes** (For colorectal cancer) Lung Targeted Profile 7 genes** (For non-small cell lung cancer) Melanoma Targeted Profile 8 genes** (For metastatic melanoma) CNS Molecular Profile 25 genes** NexCourse Complete 236 genes** III. SECOND OPINION CONSULTATION*** Initial Impression: *If not all tests are indicated, please select only the medically necessary tests from the individual test list provided. **See reverse for list of genes. ***A second opinion consultation will be issued when submitted records include first opinion/diagnosis/microscopic impression. A first opinion pathologist microscopic interpretation may be reported and billed instead, depending on the records provided. FOR LAB USE ONLY HIGHLIGHTED FIELDS ARE REQUIRED INFORMATION. CLIENT INFORMATION PATIENT INFORMATION Account # Last Name Account Name First Name Address Patient Social Security # Phone # Ordering Physician DOB Sex: Male Female MRN/PT # Treating/Rendering Physician Street Phone # NPI City State Zip Authorized Signature Date SPECIMEN/CLINICAL INFORMATION BILLING INFORMATION Clinical information including patient history and recent CBC should be provided. Please attach a copy of the patient s insurance card. ICD-10 Code(s) Bill to: Insurance Medicare Patient My Account (Hospital/Client) Collection date (mm/dd/yy) Time Patient Status: Hospital Inpatient Hospital Outpatient Non-hospital patient Specimen ID# Body site Hospital Discharge Date (if hospital in/outpatient) Specimen Source (Please select one) Authorization/Referral # Bone Marrow: Green top(s) Purple top(s) Core Clot Healthplan Name/IPA Peripheral Blood: Green top(s) Purple top(s) Other Medicare/Policy # Group Plan # Smears: PB BM Touch preps Claims Address Slides: Stained Unstained Paraffin Block(s) Name of Insured Ins Phone Other: Fluid Tissue Type: Relationship to insured: Self Spouse Child Other Diagnosis under consideration Secondary Insurance: No Yes (If yes, please attach) Clinical History Prior therapy: No Yes, details This is a staging for lymphoma. Subtype I would like a Genoptix Hematopathologist to call me to discuss the case. Preferred phone number: SERVICE OPTIONS (SELECT ONE) I want Genoptix to request the specimen. (COMPLETE the information below.) Specimen enclosed. (Refer to back of requisition for specimen requirements.) LOCATION OF TISSUE SPECIMEN SPECIMEN ID ARCHIVE RETRIEVAL DATE PHONE FAX If specimen quantity and/or quality is not sufficient for NGS, Genoptix pathologist will direct PCR, FISH and IHC testing as medically appropriate. Do not run PCR, FISH or IHC assays instead of NGS. I. Hematology Molecular Tests (Includes interpretation) II. Solid Tumor Molecular Tests (Includes interpretation) Myeloid Molecular Profile by Next-Gen Sequencing 44 genes* CRC Targeted Profile by Next-Gen Sequencing 3 genes* (For determination of a malignant clonal process) (For colorectal cancer) MPN Targeted Profile by Next-Gen Sequencing 5 genes* Lung Targeted Profile 7 genes* by Next-Gen Sequencing plus ALK, ROS1 and (For MPN subclassification) RET by FISH and PD-L1 22C3 by IHC CLL Targeted Profile by Next-Gen Sequencing 5 genes* Lung Targeted Profile by Next-Gen Sequencing 7 genes* AML Molecular Profile all 24 genes* by Next-Gen Sequencing plus MLL-PTD ALK Rearrangement by FISH and FLT3 by PCR RET Rearrangement by FISH AML Molecular Profile by Next-Gen Sequencing 24 genes* ROS1 Rearrangement by FISH MLL-PTD Mutation Analysis by PCR PD-L1 22C3 by IHC FLT3 Mutation Analysis by PCR Melanoma Targeted Profile by Next-Gen Sequencing 8 genes* Lymphoid Molecular Profile by Next-Gen Sequencing all 128 genes* (For metastatic melanoma) CNS Molecular Profile by Next-Gen Sequencing 25 genes* III. Comprehensive Molecular Profiling (Includes interpretation) CLL Comprehensive Profile by Next-Gen Sequencing 48 genes* NexCourse Complete by Next-Gen Sequencing 236 genes* (For clinically relevant genomic alterations) *See reverse for list of genes. NOTES: FOR LAB USE ONLY Tired of paper requisitions? Save time and place your test order on Genoptix Online (go.genoptix.com) instead! Tired of paper requisitions? Save time and place your test order on Genoptix Online (go.genoptix.com) instead! Tired of paper requisitions? Save time and place your test order on Genoptix Online (go.genoptix.com) instead! HEMATOLOGY TEST REQUISITION The Hematology requisition includes our COMPASS service and is used to order testing for blood disorders. SOLID TUMOR TEST REQUISITION Use the Solid Tumor test requisition solid tumor molecular profi ling, using state-of-the-art molecular and next-generation sequencing technologies. GENOMIC PROFILING TEST REQUISITION Use the Genomic Profi ling test requisition to order molecular profi le testing that uses state-of-the-art molecular and next-generation sequencing technologies. 2 GO.GENOPTIX.COM ONLINE ORDERING AND REPORTING PORTAL

7 Medicare and other third party payors require that services be medically necessary for coverage. Medicare generally does not cover routine screening tests. Accession will expire after 24 hours unless contacted by client interpretation may be reported and billed instead, depending on the records provided. v See reverse for list of genes. licensure under federal law (Clinical Laboratory Improvement Amendments) and state law (clinical laboratory licensure). 1 LAB COPY 2 CLIENT COPY APRIL 2017 PARQ Medicare and other third party payors require that services be medically necessary for coverage. Medicare generally does not cover routine screening tests. By ordering only the technical component services from Genoptix, the interpreting physician acknowledges and accepts responsibility for performing the professional interpretation for these tests and represents that she/he is performing this professional service compliant with all applicable certifications and licensure under federal law (Clinical Laboratory Improvement Amendments) and state law (clinical laboratory licensure). 1 LAB COPY 2 CLIENT COPY APRIL 2017 IHCRQ Genoptix and GenoTrace are registered trademarks of Genoptix, Inc Genoptix, Inc. April LAB COPY 2 CLIENT COPY BCRRQ FLEXIBLE S GENOPTIX TESTING DIRECTORY Genoptix offers several ways in which our customers can order oncology testing services: INTERFACE CONNECTIVITY We have dedicated internal IT experts to design and implement custom interfaces for a variety of Electronic Health Records (EHR) and Laboratory Information System (LIS) platforms. ONLINE ORDERING Customers with a Genoptix Online account can order testing through our secure, interactive and easy-to-use online portal. TEST REQUISITION FORMS We offer six unique test requisition forms to address different customer needs, to tailor and simplify the product offering for each testing scenario. GLOBAL (TC/PC) Global (TC/PC) includes both the Technical Component (TC) and Professional Component (PC), meaning Genoptix will perform the testing and also provide the interpretation of the results. TECH-ONLY (TC) Our Pathology and Hospital clients can order technical component services from Genoptix. We perform the test-specifi c sample preparation and processing to produce result data, while enabling our customers to easily analyze and interpret the results via our Report Builder tool. SPECIMEN HOLD OPTIONS At no cost to our customers, our lab will stabilize the specimen upon receipt to enable our customers to work up the initial component of testing Rutherford Road Carlsbad, CA HEMATOLOGY/ONCOLOGY Client Services & Specimen REQUISITION Pick Up Fax HIGHLIGHTED FIELDS ARE REQUIRED INFORMATION. CLIENT INFORMATION PATIENT INFORMATION Account # Last Name First Name Account Name Patient SSN DOB Sex: M F Address Phone # Street Ordering Physician City/State/Zip MRN/PT # Treating/Rendering Physician COG Patient Phone # NPI SPECIMEN/CLINICAL INFORMATION Authorized Signature Date Clinical information including patient history and recent CBC should be provided. BILLING INFORMATION ICD-10 Code(s) Please attach a copy of the patient s insurance card. Bill to: Insurance Medicare My Account (Hospital/Client) Collection date (mm/dd/yy) Time Patient Status: Hospital Inpatient Hospital Outpatient Non-hospital patient Specimen ID# Body site Hospital Discharge Date (if hospital in/outpatient) Specimen Source (Please select one) Authorization/Referral # Bone Marrow: Green top(s) Purple top(s) Core Clot Healthplan Name/IPA Peripheral Blood: Green top(s) Purple top(s) Other Medicare/Policy # Group Plan # Smears: PB BM Touch preps Claims Address Slides: Stained Unstained Paraffin Block(s) Name of Insured Ins Phone Other: Fluid Tissue Type: Relationship to insured: Self Spouse Child Other Secondary Insurance: No Yes (If yes, please attach) Diagnosis under consideration Clinical History Prior therapy: No Yes, details FOR LAB USE ONLY This is a staging for lymphoma. Subtype SERVICE OPTIONS (SELECT ONE) I want Genoptix to request the specimen. (COMPLETE the information below.) Specimen enclosed. (Refer to back of requisition for specimen requirements.) LOCATION OF TISSUE SPECIMEN SPECIMEN ID ARCHIVE RETRIEVAL DATE PHONE FAX If specimen quantity and/or quality is not sufficient for NGS, Genoptix pathologist will direct PCR, FISH and IHC testing as medically appropriate. Do not run PCR, FISH or IHC assays instead of NGS. COMPASS SELECT OPTIONS III. Next-Gen Sequencing (Includes interpretation) Includes COMPASS Consultation Report, clinical pathology evaluation, bone marrow and/or blood morphology (Up to 20 Hematology stains and/or antibodies), flow cytometry (Up to 40 antibodies), cytogenetics and/or FISH (Up to 14 probes), and molecular Myeloid Molecular Profile v CLL Targeted Profile v CLL Comprehensive Profile v testing (includes interpretation) as medically necessary; a consultative review and correlation with all prior findings is MPN Targeted Profile v NexCourse Complete v performed by a Genoptix hematopathologist (when appropriate). AML Molecular Profile v Lymphoid Molecular Profile v Solid Tumor COMPASS Select without Morphology. I will provide morphology report. Lung Targeted Profile v CRC Targeted Profile COMPASS Select without Flow. I will provide flow report. v Melanoma Targeted Profile v CNS Molecular Profile COMPASS Select without Cytogenetics. I will provide cytogenetics report. v IV. Flow Cytometry (Global unless otherwise noted) If medically appropriate, perform applicable NGS profile (Myeloid and Lymphoid disorders only; Intelligent Flow Profile (Up to 40 markers) Global Tech Only includes interpretation). B-ALL MRD (Previously treated ALL patients) PNH Evaluation Test Information: Based on medical necessity, Genoptix hematopathologists will select the necessary special stains, antibodies, FISH probe(s), or molecular tests. You will be provided with a diagnosis from the technologies performed. CLL MRD (Previously treated CLL patients) Myeloma MRD (Previously treated Myeloma patients) INDIVIDUAL TECHNOLOGIES V. Cytogenetics (Separate reports) Chromosome analysis FISH (Up to 14 probes, as medically necessary) SPECIMEN HOLD OPTIONS VI. FISH Cytogenetics: Molecular Testing: Flow Cytometry: Indicate level of service to be performed. Culture and Hold Extract Nucleic Acid Process and Hold Global FISH (With Interpretation) Tech-Only (No Interpretation) Chromosome Analysis and Hold Culture and Hold FISH UroVysion Bladder Cancer (Global Only) Hematology FISH Profiles I. Bone Marrow/Blood Morphology (Up to 20 stains and/or antibodies) ALL CML MDS Extended MPN Eosinophilia II. Molecular Tests (Includes interpretation) AML MM MDS Standard NHL Hematology CLL MM i-fish* MPN GenoTRACE Quantitative BCR-ABL MPL Mutation Analysis Individual FISH Probes for Hematology ABL1 Kinase Domain Mutation IgVH Hypermutation Analysis ALK/Lymphoma (2p23) FGFR1 (8p11) MLL (11q23) TP53 (17p13) CALR Mutation Analysis FLT3/NPM1 Mutation Analysis API2/MALT1 t(11;18) IGH (14q32) MYC (8q24) 5q-/-5/+5 JAK2 Exon FLT3 Mutation Analysis ATM (11q22) IGH/BCL2 t(14;18) PDGFRα (4q12) 6q21/6q23 T-Cell Clonality Assessment Beta Gamma KIT (D816V) Mutation Analysis BCL6 (3q27) IGH/CCND1 t(11;14) PDGFRβ (5q32) 7q-/-7 B-Cell Clonality Assessment PML/RARA Quantitative BCR-ABL/ASS1 t(9;22) IGH/FGFR3 t(4;14) PML/RARA t(15;17) +8 JAK2 V617F Mutation Analysis MLL-PTD Mutation Analysis CBFβ/MYH11 inv(16) IGH/MAF t(14;16) RARA (17q21) +12 If JAK2 V617F is negative, perform MPN Targeted Profile 5 genes CKS1B/CDKN2C (1p/1q) IGH/MYC t(8;14) RUNX1T1/RUNX1 t(8;21) 13q-/-13 If JAK2 V617F is negative, perform CALR MPL JAK2 Exon ETV6/RUNX1 t(12;21) MALT1 (18q21) TCRα/d (14q11) 20q- Solid Tumor Individual FISH Probes for Solid Tumor BRAF Mutation Analysis (for non-melanoma) MSI Analysis ALK rearrangement HER2 amplification RET rearrangement (Global Only) THxID BRAF Mutation Analysis (for Melanoma) EGFR Mutation Analysis FGFR1 amplification (Global Only) MET amplification ROS1 rearrangement VII. Second Opinion Consultation** Initial Impression: NOTES: Tired of paper requisitions? Save time and place your test order on Genoptix Online (go.genoptix.com) instead! *Includes plasma cell enrichment on specimens of sufficient cellularity. Specimen should be received at Genoptix within 96 hours of collection. **A second opinion consultation will be issued when submitted records include first opinion/diagnosis/microscopic impression. A first opinion pathologist microscopic By ordering only the technical component services from Genoptix, the interpreting physician acknowledges and accepts responsibility for performing the professional interpretation for these tests and represents that she/he is performing this professional service compliant with all applicable certifications and 2110 Rutherford Road Carlsbad, CA IHC/SPECIAL STAINS Client Services & Specimen REQUISITION Pick Up Fax HIGHLIGHTED FIELDS ARE REQUIRED INFORMATION. CLIENT INFORMATION PATIENT INFORMATION Account # Last Name First Name Account Name Patient SSN DOB Sex: M F Address Phone # Street Ordering Physician City/State/Zip MRN/PT # Treating/Rendering Physician SPECIMEN/CLINICAL INFORMATION Phone # NPI Clinical information including patient history should be provided. Authorized Signature Date BILLING INFORMATION ICD-10 Code(s) Please attach a copy of the patient s insurance card. Collection date (mm/dd/yy) Time Bill to: Insurance Medicare My Account (Hospital/Client) Specimen ID# Body site Patient Status: Hospital Inpatient Hospital Outpatient Non-hospital patient Specimen Source (Please select one) Hospital Discharge Date (if hospital in/outpatient) Bone marrow: Green top(s) Purple top(s) Core Other Authorization/Referral # Slides: Unstained Paraffin Block(s) Healthplan Name/IPA Other: Fluid Tissue Type: Medicare/Policy # Group Plan # Diagnosis under consideration Claims Address Clinical History Name of Insured Ins Phone Prior therapy: No Yes, details Relationship to insured: Self Spouse Child Other This is a staging for lymphoma. Subtype Secondary Insurance: No Yes (If yes, please attach) BREAST IMAGE ANALYSIS TECH ONLY ER PR HER2 Ki67 IMMUNOHISTOCHEMISTRY (IHC) INDICATE LEVEL OF SERVICE TO BE PERFORMED: GLOBAL IHC (WITH INTERPRETATION) TECH-ONLY (NO INTERPRETATION) 34BE12 (CK 903) AACT AAT ACTH Actin Adipophilin AE1/AE3 AFP Alk-1 Protein Androgen Receptor Annexin-A1 Arginase-1 Bcl-1 (Cyclin D1) Bcl-2 oncoprotein Bcl-6 Ber-EP4 Beta-Catenin B72.3 C4d CAIX (Carbonic Anhydrase) Calcitonin Caldesmon Calponin Calretinin CAM5.2 CD1a CD2 CD3 CD4 CD5 CD7 CD8 CD10 CD11c CD14 CD15 CD19 CD20 CD21 CD22 CD23 CD25 CD30 CD31 CD33 CD34 CD42b CD43 (Leu22) CD44 CD45 (LCA) CD45RO (UCHL-1) CD56 CD57 (Leu7) CD61 CD68 (KP1) CD71 CD79a CD99-MIC-2 CD103 CD117 (c-kit) CD123 CD138 CD163 CDH17 CDX-2 CEA (Monoclonal) CEA (Polyclonal) Chromogranin A CK5 CK7 CK19 CK20 CMV D2-40 DBA.44 (HCL) Desmin DOG-1 E-Cadherin EBV (EBER) by ISH EBV-LMP EMA ERG ER Factor VIII Factor XIIIa Fascin INDICATE ANTIBODIES TO BE PERFORMED FSH Myogenin Galectin-3 Myoglobin Gastrin Napsin A GATA-3 Neurofilament GCDFP (BRST-2) NKX3.1 GFAP OCT 3/4 Glucagon OSCAR broad spectrum keratin Glutamine synthetase P504S Glycophorin-A P16 Glypican-3 P40 Granzyme B P53 Growth Hormone P57 HBME-1 P63 HCG Beta P120-Catenin Helicobacter pylori PAP (Prostatic Acid Phos.) Hemoglobin A Pancreatic polypeptide Hepatitis B Core Ag Parvovirus B19 Hepatitis B Surface Ag Pax-5 Hep-Par1 (Hepat Sp Ag) Pax-8 HER2 (IHC) PD-1 HHV8 PD-L1 22C3 (Global Only) HMB45 PTH HSV1/HSV2 Cocktail Perforin Ig A PG-M1 Ig D PIN-4 (Prostate triple stain) Ig G Placental Lactogen IgG4 PLAP (Placental Alk. Phos.) Ig M PMS2 Inhibin-A PR Insulin Prolactin Kappa PSA Kappa CISH RCC Ki-67 (MIB-1) S100 Lambda S100P Lambda CISH SALL4 Laminin Serotonin LH SMA (Smooth Muscle Actin) Lysozyme SMM heavy chain Mammaglobin Somatostatin MART-1 SOX10 MITF SOX11 MLH1 SV40 MOC-31 Synaptophysin MSH2 T-bet MSH6 TdT MUM-1 Thyroglobulin MYC (c-myc) TSH Myelin Basic Protein TIA-1 Myeloperoxidase Toxoplasma gondii Tired of paper requisitions? Save time and place your test order on Genoptix Online (go.genoptix.com) instead! TRAP TTF-1 Tyrosinase Tryptase (Mast Cell) Uroplakin II Varicella Zoster Ubiquitin Villin Vimentin WT-1 ZAP-70 SPECIAL STAINS / ORGANISMS AFB Alcian Blue/PAS Alcian Blue Alcian Blue & Hyaluronidase Amyloid (crystal violet) Argyrophil (carcinoid) Argentaffin Basement membrane (Gomori) Bile Brown & Hopps (Gram) Colloidal Iron with/without hyaluronidase Congo Red Copper Diff Quik Elastic Fite Giemsa GMS Iron Keratin (Ayoub-Shklar) Melanin (Fontana-Masson) Melanin-Bleach Methyl Green Pyronine Movat s Pentachrome Mucicarmine Oil Red O PAS-F PTAH Reticulum Steiner & Steiner (Spirochetes) Toluidine Blue (mast cell) Trichrome Victoria Blue Wright Giemsa CLIENT INFORMATION Account # Account Name Address Ordering Physician Treating/Rendering Physician Phone # NPI Authorized Signature Date BILLING INFORMATION Your patient may be eligible to receive free GenoTRACE BCR-ABL testing through the Novartis Get IS RQ-PCR Now program.* Please check below if your patient is eligible and you would like your patient to receive testing under the program.** Please provide testing for my patient under the Novartis Get IS RQ-PCR Now program. In the event my patient is ineligible for the Novartis Get IS RQ-PCR Now program, please proceed with commercial testing and bill insurance as appropriate. *The Novartis Get IS RQ-PCR Now testing program is NOT available to (i) non-us residents, (ii) patients who receive insurance benefits wholly or in part through the government (e.g. Medicare, Medicaid or a similar state or federal program), or (iii) patients who reside in Michigan or Massachusetts. **This section must be completed each time you would like your patient to receive testing under the program. Please attach a copy of the patient s insurance card. Bill to: Insurance Medicare Patient My Account (Hospital/Client) Patient Status: Inpatient Outpatient Non-hospital patient Hospital Discharge Date (if hospital in/outpatient) Authorization/Referral # Healthplan Name/IPA Medicare/Policy # Group Plan # Claims Address Name of Insured Ins Phone Relationship to insured: Self Spouse Child Other Secondary Insurance: No Yes (If yes, please attach) MOLECULAR TEST (Box must be checked to be processed) GenoTRACE Quantitative BCR-ABL NOTES: FOR LAB USE ONLY GENOTRACE BCR-ABL TEST REQUISITION HIGHLIGHTED FIELDS ARE REQUIRED INFORMATION. PATIENT INFORMATION Last Name First Name Patient Social Security # Phone # DOB Sex: Male Female MRN/PT # Street City State Zip SPECIMEN/CLINICAL INFORMATION Clinical information including patient history should be provided. ICD-10 Code(s) Collection date (mm/dd/yy) Time Specimen ID# Specimen Requirements One (1) 3mL purple top EDTA tube If WBC <5,000, please send two 3mL purple top EDTA tubes Indicate type of specimen and # of tubes. Blood Purple Top (EDTA) Initial Evaluation for CML Existing CML Patient Other Diagnosis under consideration / Need to address the following clinical question? 2110 Rutherford Road Carlsbad, CA Client Services & Specimen Pick Up Fax Initial Date of Diagnosis / / Has the patient reached CCyR? Yes No Clinical History (Please attach recent summary of patient history or notes from recent clinic visit) SPECIMEN LABEL INSTRUCTIONS: 1. Complete the requisition with all the requested information. 2. Clearly print patient name and date of birth on the attached labels. 3. Place one (1) label on each specimen (not on the lid). Patient Name Date of Birth 1. Complete test requisition form. Include patient insurance information and appropriate clinical data. Retain the bottom copy for your records. 2. To send a specimen, call Genoptix at for pick up. Genoptix, Inc Rutherford Road, Carlsbad, CA Client Services: Fax: genoptix.com Tired of paper requisitions? Save time and place your test order on Genoptix Online (go.genoptix.com) instead! Patient Name Date of Birth HEMATOLOGY/ONCOLOGY TEST REQUISITION The Hematology/Oncology test requisition is our most comprehensive requisition and is used by Hospitals and Reference Labs to order tests to aid in cancer patient management. IMMUNOHISTOCHEMISTRY (IHC) AND SPECIAL STAINS TEST REQUISITION Our broad menu of IHC/special stains has its own test requisition that is used by pathologists to assist in the diagnosis of various cancers. BCR/ABL TEST REQUISITION Our BCR/ABL test requisition is used to order testing for patients with suspected chronic myelogenous leukemia (CML), and to monitor those undergoing therapy for CML CLIENT SERVICES 3

8 COMPASS and The Genoptix Way are ideal for the oncology practice meaning Genoptix assigns one hematopathologist to follow each patient s case from start to fi nish, and provides the clinician with one comprehensive assessment report. Patient Name Sex F Date of Birth Patient ID Accession # Ordering Physician Account # Clien lient Client Add dre ess 2110 Rutherford Rd Bashar Dabbas, MD Carlsbad, CA Laboratory Director Client Services: CLIA ID #D05D101 Fax: CAP # S pecimen Bone Marrow Collec llecte ed 8/6/ :15:00 AM R ecei ive ed 8/7/ :50:00 AM Repor porte ed 9/17/ :28:00 AM HEMATOLOGY REQUISITION 2110 Rutherford Road Carlsbad, CA Client Services & Specimen Pick Up Fax Telephone # COM MPASS S Clinical Histor y Previous Chart Report shows peripheral blood with persistent thrombocytosis, with molecular analysis positive for a mutation in the DNMT3A gene; Myeloid Molecular Profile Report shows a pathogenic mutation in the DNMT3A gene (collected 5/12/15). Previous Chart Report reveals blood with no clonal abnormalities (collected 8/12/2014). Initial Compass Report shows peripheral blood with thrombocytosis and no evidence of a clonal abnormalities (collected 11/6/2013). Evaluate for essential thrombocythemia and rule out myelodysplastic syndrome. No concurrent CBC data are provided with specimen. HIGHLIGHTED FIELDS ARE REQUIRED INFORMATION. CLIENT INFORMATION PATIENT INFORMATION Account # Last Name First Name Account Name Patient SSN DOB Sex: M F Address Phone # Street City/State/Zip MRN/PT # Ordering Physician COG Patient Treating/Rendering Physician SPECIMEN/CLINICAL INFORMATION Phone # NPI Clinical information including patient history and recent CBC should be provided. Authorized Signature Date ICD-10 Code(s) BILLING INFORMATION Please attach a copy of the patient s insurance card. Collection date (mm/dd/yy) Time Bill to: Insurance Medicare Patient My Account (Hospital/Client) Specimen ID# Body site Patient Status: Hospital Inpatient Hospital Outpatient Non-hospital patient Specimen Source (Please select one) Hospital Discharge Date (if hospital in/outpatient) Bone Marrow: Green top(s) Purple top(s) Core Clot Authorization/Referral # Peripheral Blood: Green top(s) Purple top(s) Other Healthplan Name/IPA Smears: PB BM Touch preps Medicare/Policy # Group Plan # Slides: Stained Unstained Paraffin Block(s) Other: Fluid Tissue Type: Claims Address Name of Insured Ins Phone Diagnosis under consideration Relationship to insured: Self Spouse Child Other Clinical History Secondary Insurance: No Yes (If yes, please attach) Prior therapy: No Yes, details Medicare and other third party payors require that services be medically necessary for coverage. This is a staging for lymphoma. Subtype Medicare generally does not cover routine screening tests. I would like a Genoptix Hematopathologist to call me to discuss the case. Preferred phone number: SERVICE OPTIONS (SELECT ONE) I want Genoptix to request the specimen. (COMPLETE the information below.) Specimen enclosed. (Refer to back of requisition for specimen requirements.) LOCATION OF TISSUE SPECIMEN SPECIMEN ID ARCHIVE RETRIEVAL DATE PHONE FAX FINAL DIAGN NOSIS : C ELLULARL BONE MARROW WITH MILDLY INCREASED ED MEGAKARYOCYTES AND WITH MOLECULAR EVIDENCE OF CLONAL HEMATOPOIESI S (PRESENCE OF DNMT3A GENE MUTATION) T. Comp mprehensi hensive e Asse sessmen sment This bone marrow specimen shows trilineage hematopoiesis with no significant increase in blasts. Megakaryocytes are mildly increased. Flow cytometric analysis does not detect any monotypic B- lymphocyte or aberrant T-cell population. The peripheral blood specimen is remarkable for the thrombocytosis. Cytogenetic studies reveal a normal karyotype and no abnormalities are detected by FISH. No JAK2, MPL, or CALR mutations are observed (also negative on previous peripheral blood studies); moreover, no TPHO mutation is identified, thus essentially ruling out many conditions of hereditary thrombocytosis. However, molecular analysis detects a pathogenic mutation in the DNMT3A gene (also observed previously). Therefore, the findings are consistent with clonal hematopoiesis. Although there is no overt morphologic marrow evidence of a MPN, the presence of persistence thrombocytosis on a background of clonal hematopoiesis raises a concern for an early evolving MPN which cannot be entirely excluded at the moment. Clinical correlation and follow-up are recommended. Dr. Xun Li has reviewed select slides and concurs. Morphology Bone marrow aspirate, core biopsy, and peripheral blood: Cellular bone marrow with trilineage hematopoiesis; mildly increased megakaryocytes; no significant increase in blasts; peripheral blood with thrombocytosis. Fl low Cytometr metry Bone marrow aspirate with no significant immunophenotypic abnormalities. C ytogenetics/fish Cytogenetic analysis reveals a NORMAL female karyotype without apparent clonal aberrations. MPN FISH: NORMAL results. FISH analysis do not detect aberrations in the 200 nuclei/probe examined. H ereditary e Thrombo mbocythemia via The THPO Gene Results: NEGATIVE Results and Interpretation: In this patient, for the THPO gene, we found no sequence variants. JAK2 Mutation tion Analysi is Results are NEGATIVE for JAK2 V617F mutation. COMPASS COMPREHENSIVE ASSESSMENT Includes COMPASS Consultation Report, clinical pathology evaluation, bone marrow and/or blood morphology (Up to 20 stains and/or antibodies), flow cytometry (Up to 40 antibodies), cytogenetics and/or FISH (Up to 14 probes), and molecular testing as medically necessary; a consultative review and correlation with all prior findings is performed by a Genoptix hematopathologist (when appropriate). When serial or subsequent COMPASS Bone Marrow or Blood Evaluations are requested on the same patient and deemed clinically appropriate by a Genoptix hematopathologist, Genoptix will automatically provide a CHART (Comprehensive Hematopathology Assessment and Review over Time) Report, unless otherwise indicated by the ordering physician. CHART includes all medically necessary technologies, and a consultative review and correlation with relevant prior findings by a Genoptix hematopathologist. COMPASS Evaluation If medically appropriate, perform applicable NGS profile (Myeloid and Lymphoid disorders only; includes interpretation). Test Information: Based on medical necessity, Genoptix hematopathologists will select the necessary special stains, antibodies, FISH probe(s), or molecular tests. You will be provided with a diagnosis from the technologies performed, including morphologic evaluation where appropriate. NOTES: FOR LAB USE ONLY INDIVIDUAL TECHNOLOGIES I. Bone Marrow/Blood Morphology (Up to 20 stains and/or antibodies) II. Flow Cytometry (Up to 40 antibodies) Intelligent Flow Profile PNH Evaluation B-ALL MRD (Previously treated ALL patients) Myeloma MRD (Previously treated CLL MRD (Previously treated CLL patients) Myeloma patients) III. Chromosome Analysis/FISH Chromosome analysis and FISH as medically necessary (Up to 14 probes) Chromosome analysis (Only) FISH as medically necessary (Up to 14 probes) FISH (Indicate desired probe[s] or profile in the Notes Section) IV. Molecular Tests (Includes interpretation) GenoTRACE Quantitative BCR-ABL MPL Mutation Analysis ABL1 Kinase Mutation Analysis lgvh Hypermutation Analysis CALR Mutation Analysis FLT3/NPM1 Mutation Analysis JAK2 Exon 12/13 FLT3 Mutation Analysis T-Cell Clonality Assessment Beta Gamma KIT (D816V) Mutation Analysis B-Cell Clonality Assessment PML/RARA Quantitative Analysis JAK2 V617F Mutation Analysis MLL-PTD Mutation Analysis If JAK2 V617F is negative, perform MPN Targeted Profile 5 genes* If JAK2 V617F is negative, perform CALR MPL JAK2 Exon V. Next-Gen Sequencing (Includes interpretation) Myeloid Molecular Profile 44 genes* Lymphoid Molecular Profile 128 genes* MPN Targeted Profile 5 genes* CLL Comprehensive Profile 48 genes* CLL Targeted Profile 5 genes* NexCourse Complete 236 genes* AML Molecular Profile 24 genes* VI. Second Opinion Consultation** Initial Impression: *See reverse for a list of genes in each profile. **A second opinion consultation will be issued when submitted records include first opinion/diagnosis/microscopic impression. A first opinion pathologist microscopic interpretation may be reported and billed instead, depending on the records provided. Myeloid Molecular Profil e Pathogenic alteration is DETECTED in the DNMT3A gene. Genomic alteration of uncertain significance is DETECTED in the GATA2 gene. 9/17/2015 Electronically Signed By Date A nthonyn Padula, M.D. Senior Hematopathologist For detailed information on any of the tests performed, please refer to the individual test reports. Page 1 of 1 COMPASS is a comprehensive and fl exible assessment that takes the guesswork out of your oncological bone marrow and blood workups. Tired of paper requisitions? Save time and place your test order on Genoptix Online (go.genoptix.com) instead! COMPASS can be ordered from the Hematology Test Requisition. 1 LAB COPY 2 CLIENT COPY APRIL 2017 RQ Receive accurate and actionable diagnoses in a brief (one-page), easy-to-understand correlated report. Physician-directed customization integrates a diverse range of technologies to produce results you can rely on. A dedicated hematopathologist is assigned to each patient case to personally manage tests, integrate fi ndings, and provide individualized consultations, all to empower you to provide the best possible care to your patients. 4 GO.GENOPTIX.COM ONLINE ORDERING AND REPORTING PORTAL

9 GENOPTIX TESTING DIRECTORY CONSULTATION SERVICES COMPASS Blood Evaluation Includes COMPASS consultation report, clinical pathology evaluation, blood morphology (up to 10 cytochemical stains), fl ow cytometry (up to 40 antibodies), cytogenetics and/or fl uorescent in situ hybridization (FISH) (up to 14 probes), and molecular tests as medically necessary. Refer to individual tests and technologies Refer to individual tests for the most current specimen type and requirements 10 days Refer to individual tests for CPT Code(s) Refer to individual tests COMPASS Bone Marrow Evaluation Includes COMPASS consultation report, clinical pathology evaluation, bone marrow morphology (up to 20 stains and/or IHC antibodies), fl ow cytometry (up to 40 antibodies), cytogenetics and/or fl uorescent in situ hybridization (FISH) (up to 14 probes), and molecular tests as medically necessary. Refer to individual tests and technologies Refer to individual tests for the most current specimen type and requirements 10 days Refer to individual tests for CPT Code(s) Refer to individual tests COMPASS is a registered trademark of Genoptix, Inc CLIENT SERVICES 5

10 CONSULTATION SERVICES COMPASS Select without Morphology The client s pathologist must provide the morphology report to Genoptix. COMPASS Select includes the COMPASS consultation report, clinical pathology evaluation, flow cytometry (up to 40 antibodies), cytogenetics and/or fluorescent in situ hybridization (FISH) (up to 14 probes), and molecular tests as medically necessary. Refer to individual tests and technologies Refer to individual tests for the most current specimen type and requirements 10 days Refer to individual tests for CPT Code(s) Refer to individual tests COMPASS Select without Flow The client s pathologist must provide the flow cytometry report to Genoptix. COMPASS Select includes the COMPASS consultation report, clinical pathology evaluation, bone marrow morphology (up to 20 stains and/or IHC antibodies), cytogenetics and/or fluorescent in situ hybridization (FISH) (up to 14 probes), and molecular tests as medically necessary. Refer to individual tests and technologies Refer to individual tests for the most current specimen type and requirements 10 days Refer to individual tests for CPT Code(s) Refer to individual tests COMPASS Select is a trademark of Genoptix, Inc. 6 GO.GENOPTIX.COM ONLINE ORDERING AND REPORTING PORTAL

11 GENOPTIX TESTING DIRECTORY COMPASS Select without Cytogenetics The client s pathologist must provide the cytogenetics report to Genoptix. COMPASS Select includes the COMPASS consultation report, clinical pathology evaluation, blood or bone marrow morphology (up to 20 stains and/or IHC antibodies), fl ow cytometry (up to 40 antibodies), and molecular tests as medically necessary. Refer to individual tests and technologies Refer to individual tests for the most current specimen type and requirements 10 days Refer to individual tests for CPT Code(s) Refer to individual tests COMPASS Select is our unique comprehensive assessment approach for bone marrow and blood workups. It integrates individual test results (morphology, fl ow cytometry or cytogenetics) performed by the local pathologist into our physician-directed case workup utilizing all technologies, as medically necessary, for diagnosis Rutherford Road Carlsbad, CA HEMATOLOGY/ONCOLOGY Client Services & Specimen REQUISITION Pick Up Fax HIGHLIGHTED FIELDS ARE REQUIRED INFORMATION. CLIENT INFORMATION PATIENT INFORMATION Account # Last Name First Name Account Name Patient SSN DOB Sex: M F Address Phone # Street Ordering Physician City/State/Zip MRN/PT # Treating/Rendering Physician COG Patient Phone # NPI SPECIMEN/CLINICAL INFORMATION Authorized Signature Date Clinical information including patient history and recent CBC should be provided. BILLING INFORMATION ICD-10 Code(s) Please attach a copy of the patient s insurance card. Bill to: Insurance Medicare My Account (Hospital/Client) Collection date (mm/dd/yy) Time Patient Status: Hospital Inpatient Hospital Outpatient Non-hospital patient Specimen ID# Body site Hospital Discharge Date (if hospital in/outpatient) Specimen Source (Please select one) Authorization/Referral # Bone Marrow: Green top(s) Purple top(s) Core Clot Healthplan Name/IPA Peripheral Blood: Green top(s) Purple top(s) Other Medicare/Policy # Group Plan # Smears: PB BM Touch preps Claims Address Slides: Stained Unstained Paraffin Block(s) Name of Insured Ins Phone Other: Fluid Tissue Type: Relationship to insured: Self Spouse Child Other Secondary Insurance: No Yes (If yes, please attach) Diagnosis under consideration Clinical History Prior therapy: No Yes, details Medicare and other third party payors require that services be medically necessary for coverage. Medicare generally does not cover routine screening tests. This is a staging for lymphoma. Subtype SERVICE OPTIONS (SELECT ONE) I want Genoptix to request the specimen. (COMPLETE the information below.) Specimen enclosed. (Refer to back of requisition for specimen requirements.) LOCATION OF TISSUE SPECIMEN SPECIMEN ID ARCHIVE RETRIEVAL DATE PHONE FAX If specimen quantity and/or quality is not sufficient for NGS, Genoptix pathologist will direct PCR, FISH and IHC testing as medically appropriate. Do not run PCR, FISH or IHC assays instead of NGS. COMPASS SELECT OPTIONS III. Next-Gen Sequencing (Includes interpretation) Includes COMPASS Consultation Report, clinical pathology evaluation, bone marrow and/or blood morphology (Up to 20 Hematology stains and/or antibodies), flow cytometry (Up to 40 antibodies), cytogenetics and/or FISH (Up to 14 probes), and molecular Myeloid Molecular Profile v CLL Targeted Profile v CLL Comprehensive Profile v testing (includes interpretation) as medically necessary; a consultative review and correlation with all prior findings is MPN Targeted Profile v NexCourse Complete v performed by a Genoptix hematopathologist (when appropriate). AML Molecular Profile v Lymphoid Molecular Profile v Solid Tumor COMPASS Select without Morphology. I will provide morphology report. Lung Targeted Profile v CRC Targeted Profile COMPASS Select without Flow. I will provide flow report. v Melanoma Targeted Profile v CNS Molecular Profile COMPASS Select without Cytogenetics. I will provide cytogenetics report. v IV. Flow Cytometry (Global unless otherwise noted) If medically appropriate, perform applicable NGS profile (Myeloid and Lymphoid disorders only; Intelligent Flow Profile (Up to 40 markers) Global Tech Only includes interpretation). B-ALL MRD (Previously treated ALL patients) PNH Evaluation Test Information: Based on medical necessity, Genoptix hematopathologists will select the necessary special stains, antibodies, FISH probe(s), or molecular tests. You will be provided with a diagnosis from the technologies performed. CLL MRD (Previously treated CLL patients) Myeloma MRD (Previously treated Myeloma patients) INDIVIDUAL TECHNOLOGIES V. Cytogenetics (Separate reports) Chromosome analysis FISH (Up to 14 probes, as medically necessary) SPECIMEN HOLD OPTIONS VI. FISH Cytogenetics: Molecular Testing: Flow Cytometry: Indicate level of service to be performed. Culture and Hold Extract Nucleic Acid Process and Hold Chromosome Analysis and Hold Global FISH (With Interpretation) Tech-Only (No Interpretation) Accession will expire after 24 hours Culture and Hold FISH unless contacted by client UroVysion Bladder Cancer (Global Only) Hematology FISH Profiles I. Bone Marrow/Blood Morphology (Up to 20 stains and/or antibodies) ALL CML MDS Extended MPN Eosinophilia II. Molecular Tests (Includes interpretation) AML MM MDS Standard NHL Hematology CLL MM i-fish* MPN GenoTRACE Quantitative BCR-ABL MPL Mutation Analysis Individual FISH Probes for Hematology ABL1 Kinase Domain Mutation IgVH Hypermutation Analysis ALK/Lymphoma (2p23) FGFR1 (8p11) MLL (11q23) TP53 (17p13) CALR Mutation Analysis FLT3/NPM1 Mutation Analysis API2/MALT1 t(11;18) IGH (14q32) MYC (8q24) 5q-/-5/+5 JAK2 Exon FLT3 Mutation Analysis ATM (11q22) IGH/BCL2 t(14;18) PDGFRα (4q12) 6q21/6q23 T-Cell Clonality Assessment Beta Gamma KIT (D816V) Mutation Analysis BCL6 (3q27) IGH/CCND1 t(11;14) PDGFRβ (5q32) 7q-/-7 B-Cell Clonality Assessment PML/RARA Quantitative BCR-ABL/ASS1 t(9;22) IGH/FGFR3 t(4;14) PML/RARA t(15;17) +8 JAK2 V617F Mutation Analysis MLL-PTD Mutation Analysis CBFβ/MYH11 inv(16) IGH/MAF t(14;16) RARA (17q21) +12 If JAK2 V617F is negative, perform MPN Targeted Profile 5 genes CKS1B/CDKN2C (1p/1q) IGH/MYC t(8;14) RUNX1T1/RUNX1 t(8;21) 13q-/-13 If JAK2 V617F is negative, perform CALR MPL JAK2 Exon ETV6/RUNX1 t(12;21) MALT1 (18q21) TCRα/d (14q11) 20q- Solid Tumor Individual FISH Probes for Solid Tumor BRAF Mutation Analysis (for non-melanoma) MSI Analysis ALK rearrangement HER2 amplification RET rearrangement (Global Only) THxID BRAF Mutation Analysis (for Melanoma) EGFR Mutation Analysis FGFR1 amplification (Global Only) MET amplification ROS1 rearrangement VII. Second Opinion Consultation** Initial Impression: NOTES: *Includes plasma cell enrichment on specimens of sufficient cellularity. Specimen should be received at Genoptix within 96 hours of collection. **A second opinion consultation will be issued when submitted records include first opinion/diagnosis/microscopic impression. A first opinion pathologist microscopic interpretation may be reported and billed instead, depending on the records provided. v See reverse for list of genes. By ordering only the technical component services from Genoptix, the interpreting physician acknowledges and accepts responsibility for performing the professional interpretation for these tests and represents that she/he is performing this professional service compliant with all applicable certifications and FOR LAB USE ONLY licensure under federal law (Clinical Laboratory Improvement Amendments) and state law (clinical laboratory licensure). Tired of paper requisitions? Save time and place your test order on Genoptix Online (go.genoptix.com) instead! 1 LAB COPY 2 CLIENT COPY APRIL 2017 PARQ COMPASS Select can be ordered from the Hematology/Oncology Test Requisition. If specimen quantity and/or quality is not sufficient for NGS, Genoptix pathologist will direct PCR, FIS COMPASS SELECT OPTIONS Includes COMPASS Consultation Report, clinical pathology evaluation, bone marrow and/or blood morphology (Up to 20 stains and/or antibodies), flow cytometry (Up to 40 antibodies), cytogenetics and/or FISH (Up to 14 probes), and molecular testing (includes interpretation) as medically necessary; a consultative review and correlation with all prior findings is performed by a Genoptix hematopathologist (when appropriate). COMPASS Select without Morphology. I will provide morphology report. COMPASS Select without Flow. I will provide flow report. COMPASS Select without Cytogenetics. I will provide cytogenetics report. If medically appropriate, perform applicable NGS profile (Myeloid and Lymphoid disorders only; includes interpretation). Test Information: Based on medical necessity, Genoptix hematopathologists will select the necessary special stains, antibodies, FISH probe(s), or molecular tests. You will be provided with a diagnosis from the technologies performed. INDIVIDUAL TECHNOLOGIES CLIENT SERVICES 7

12 CONSULTATION SERVICES CHART When serial or subsequent COMPASS evaluations are requested on the same patient and deemed clinically appropriate by a Genoptix Hematopathologist, Genoptix will automatically provide a CHART report, unless otherwise indicated by the ordering physician. CHART includes all medically necessary technologies, and a consultative review and correlation with relevant prior fi ndings and intervening treatment by a Genoptix Hematopathologist. Refer to individual tests and technologies SPECIMEN TYPE AND REQUIREMENT Refer to individual tests for the most current specimen type and requirements 10 days Refer to individual tests for CPT Code(s) Refer to individual tests HEMATOLOGY REQUISITION 2110 Rutherford Road Carlsbad, CA Client Services & Specimen Pick Up Fax HIGHLIGHTED FIELDS ARE REQUIRED INFORMATION. CLIENT INFORMATION PATIENT INFORMATION Account # Last Name First Name Account Name Patient SSN DOB Sex: M F Address Phone # Street City/State/Zip MRN/PT # Ordering Physician COG Patient Treating/Rendering Physician SPECIMEN/CLINICAL INFORMATION Phone # NPI Clinical information including patient history and recent CBC should be provided. Authorized Signature Date ICD-10 Code(s) BILLING INFORMATION Please attach a copy of the patient s insurance card. Collection date (mm/dd/yy) Time Bill to: Insurance Medicare Patient My Account (Hospital/Client) Specimen ID# Body site Patient Status: Hospital Inpatient Hospital Outpatient Non-hospital patient Specimen Source (Please select one) Hospital Discharge Date (if hospital in/outpatient) Bone Marrow: Green top(s) Purple top(s) Core Clot Authorization/Referral # Peripheral Blood: Green top(s) Purple top(s) Other Healthplan Name/IPA Smears: PB BM Touch preps Medicare/Policy # Group Plan # Slides: Stained Unstained Paraffin Block(s) Other: Fluid Tissue Type: Claims Address Name of Insured Ins Phone Diagnosis under consideration Relationship to insured: Self Spouse Child Other Clinical History Secondary Insurance: No Yes (If yes, please attach) Prior therapy: No Yes, details Medicare and other third party payors require that services be medically necessary for coverage. This is a staging for lymphoma. Subtype Medicare generally does not cover routine screening tests. I would like a Genoptix Hematopathologist to call me to discuss the case. Preferred phone number: SERVICE OPTIONS (SELECT ONE) I want Genoptix to request the specimen. (COMPLETE the information below.) Specimen enclosed. (Refer to back of requisition for specimen requirements.) LOCATION OF TISSUE SPECIMEN SPECIMEN ID ARCHIVE RETRIEVAL DATE PHONE FAX COMPASS COMPREHENSIVE ASSESSMENT INDIVIDUAL TECHNOLOGIES Includes COMPASS Consultation Report, clinical pathology evaluation, bone marrow and/or blood morphology (Up to I. Bone Marrow/Blood Morphology (Up to 20 stains and/or antibodies) 20 stains and/or antibodies), flow cytometry (Up to 40 antibodies), cytogenetics and/or FISH (Up to 14 probes), and II. Flow Cytometry (Up to 40 antibodies) molecular testing as medically necessary; a consultative review and correlation with all prior findings is performed by a Genoptix hematopathologist (when appropriate). Intelligent Flow Profile PNH Evaluation When serial or subsequent COMPASS Bone Marrow or Blood Evaluations are requested on the same patient and deemed B-ALL MRD (Previously treated ALL patients) Myeloma MRD (Previously treated clinically appropriate by a Genoptix hematopathologist, Genoptix will automatically provide a CHART (Comprehensive CLL MRD (Previously treated CLL patients) Myeloma patients) Hematopathology Assessment and Review over Time) Report, unless otherwise indicated by the ordering physician. III. Chromosome Analysis/FISH CHART includes all medically necessary technologies, and a consultative review and correlation with relevant prior findings by a Genoptix hematopathologist. Chromosome analysis and FISH as medically necessary (Up to 14 probes) Chromosome analysis (Only) COMPASS Evaluation FISH as medically necessary (Up to 14 probes) If medically appropriate, perform applicable NGS profile (Myeloid and Lymphoid FISH (Indicate desired probe[s] or profile in the Notes Section) disorders only; includes interpretation). IV. Molecular Tests (Includes interpretation) Test Information: Based on medical necessity, Genoptix hematopathologists will select the necessary special stains, GenoTRACE Quantitative BCR-ABL MPL Mutation Analysis antibodies, FISH probe(s), or molecular tests. You will be provided with a diagnosis from the technologies performed, ABL1 Kinase Mutation Analysis lgvh Hypermutation Analysis including morphologic evaluation where appropriate. CALR Mutation Analysis FLT3/NPM1 Mutation Analysis JAK2 Exon 12/13 FLT3 Mutation Analysis T-Cell Clonality Assessment Beta Gamma KIT (D816V) Mutation Analysis B-Cell Clonality Assessment PML/RARA Quantitative Analysis JAK2 V617F Mutation Analysis MLL-PTD Mutation Analysis If JAK2 V617F is negative, perform MPN Targeted Profile 5 genes* If JAK2 V617F is negative, perform CALR MPL JAK2 Exon V. Next-Gen Sequencing (Includes interpretation) Myeloid Molecular Profile 44 genes* Lymphoid Molecular Profile 128 genes* NOTES: MPN Targeted Profile 5 genes* CLL Comprehensive Profile 48 genes* CLL Targeted Profile 5 genes* NexCourse Complete 236 genes* AML Molecular Profile 24 genes* VI. Second Opinion Consultation** Initial Impression: *See reverse for a list of genes in each profile. **A second opinion consultation will be issued when submitted records include first FOR LAB USE ONLY opinion/diagnosis/microscopic impression. A first opinion pathologist microscopic interpretation may be reported and billed instead, depending on the records provided. Tired of paper requisitions? Save time and place your test order on Genoptix Online (go.genoptix.com) instead! 1 LAB COPY 2 CLIENT COPY APRIL 2017 RQ When serial or subsequent COMPASS Bone Marrow or Blood Evaluations are requested on the same patient and deemed clinically appropriate by a Genoptix hematopathologist, Genoptix will automatically provide a CHART (Comprehensive Hematopathology Assessment and Review over Time) Report, unless otherwise indicated by the ordering physician. CHART includes all medically necessary technologies, and a consultative review and correlation with relevant prior findings by a Genoptix hematopathologist. COMPASS Evaluation If medically appropriate, perform applicable NGS profile (Myeloid and Lymphoid disorders only; includes interpretation). Test Information: Based on medical necessity, Genoptix hematopathologists will select the necessary special stains, CHART is a registered trademark of Genoptix, Inc. 8 GO.GENOPTIX.COM ONLINE ORDERING AND REPORTING PORTAL

13 GENOPTIX TESTING DIRECTORY CONSULTATION SERVICES Second Opinion Consultation Consultation by a Genoptix Hematopathologist on previously diagnosed cases. We require appropriate clinical data and slides, as well as the most recent morphology report and laboratory test results. Cytochemistry and/or IHC Case dependent. Include all relevant slides and formalin-fi xed paraffi n embedded tissue blocks as well as the most recent relevant morphology report and laboratory test results. Additionally, if not specifi cally indicated in the morphology report, please indicate what special stains and immunohistochemistry (IHC) studies have been performed. Failure to include all the requested samples and information could lead to a delay in the completion of the consultation report days. NexCourse If one or more solid tumor tests are ordered in a disease state, a NexCourse summary report will be issued. Refer to individual tests and technologies Formalin-fi xed paraffi n embedded (FFPE) block containing non-necrotic tumor tissue, plus one (1) H&E slide cut at 4-5 microns. Acceptable Alternative: Refer to individual test days Refer to individual tests for CPT Code(s) Refer to individual tests Incomplete information on a test requisition may cause a delay in reporting (xn) (xn) (xn) (xn) and/or (xn) number of newly cut special stains evaluated and reported per unique biopsy specimen (x1) Initial immunohistochemical single stain per uniquely identifi ed biopsy specimen (xn) number of immunohistochemical stains evaluated after initial stain NexCourse is a registered trademark of Genoptix, Inc CLIENT SERVICES 9

14 CYTOGENETICS HEMATOLOGY PATHOLOGY/MORPHOLOGY CYTOGENETICS FLOW CYTOMETRY MOLECULAR EBER STAIN ON HODGKINS 10 GO.GENOPTIX.COM ONLINE ORDERING AND REPORTING PORTAL

15 PATHOLOGY/MORPHOLOGY GENOPTIX TESTING DIRECTORY Blood Morphology Preparation and staining of blood smears for the identifi cation and enumeration of blood cells. Cytochemistry Slides: Two (2) bedside smears or 1 ml of peripheral blood in EDTA (purple-top) tube. 3 days (x1) if peripheral blood smear is evaluated and reported Bone Marrow Morphology Preparation of blood smears and/or bone marrow core/clot for staining, morphological identifi cation and enumeration of hematopoietic cells. Cytochemistry and/or IHC Bone marrow aspirate: Four (4) to eight (8) bedside smears or 1 ml in EDTA (purple-top) tube. Bone marrow core: > 1.0 cm (length) in B-Plus (fi xative) vial. Place B-Plus vial in separate bag. Bone marrow clot: > 1.0 cm (length) in B-Plus (fi xative) vial. Place B-Plus vial in separate bag. Tech only: 2 days With interpretation: 3 days (x1) if bone marrow aspirate is evaluated and reported (xn) number of uniquely identifi ed bone marrow biopsy specimens evaluated and reported (e.g., core and clot sections) (xn) number of uniquely identifi ed bone marrow biopsies decalcifi ed (xn) number of special stains, microorganisms, evaluated and reported (xn) number of special stains evaluated and reported per uniquely identifi ed biopsy specimen (xn) number of immunohistochemical stains evaluated after initial stain (xn) Initial immunohistochemical single stain per uniquely identifi ed biopsy specimen (e.g., core and clot sections) or Tech-only (TC) CLIENT SERVICES 11

16 CYTOGENETICS Chromosome Analysis Detection of chromosomal gains and/or losses, as well as deletions, inversions, or translocations specific to hematopoietic disorders and malignancies. Chromosome Analysis Peripheral blood: 5-6 ml in sodium heparin (green-top) tube. Bone marrow: 2-3 ml in sodium heparin (green-top) tube. Bodily fluids: Bodily fluids for diagnostic testing of hematological cancers (subject to specimen viability): Preferred transport in equal parts RPMI. Lymphoid tissue: Transport in RPMI. 7 days (x1) (x1) (xn) (x1) LABORATORY DEVELOPED TEST (LDT) FISH Detection of chromosomal gains and/or losses, as well as deletions, inversions, or translocations specific to hematopoietic disorders and malignancies. Fluorescent in situ hybridization (FISH) Peripheral blood: 5-6 ml in sodium heparin (green-top) tube. Bone marrow: 2-3 ml in sodium heparin (green-top) tube. Bodily fluids: Bodily fluids for diagnostic testing of hematological cancers (subject to specimen viability): Preferred transport in equal parts RPMI. Lymphoid tissue: Transport in RPMI. FFPE tissue: no decalcification. Tech-only: 3 days With interpretation: 5 days Computer assisted: (x1) (xn) (xn) Manual: (x1) (xn) (xn) or Tech-only (TC) 12 GO.GENOPTIX.COM ONLINE ORDERING AND REPORTING PORTAL

17 GENOPTIX TESTING DIRECTORY CYTOGENETICS ALL FISH Profile Assessment uses BCR-ABL t(9;22), MLL (11q23), ETV6- RUNX1 t(12;21), IGH (14q32), TCR alpha/delta (14q11) for determination of acute lymphoblastic/lymphocytic leukemia. Includes CEP4 and CEP10 for pediatric acute lymphoblastic/lymphocytic leukemia. Fluorescence in situ hybridization (FISH) Peripheral blood: 5-6 ml in sodium heparin (green-top) tube. Bone marrow: 2-3 ml in sodium heparin (green-top) tube. Bodily fl uids: Bodily fl uids for diagnostic testing of hematological cancers (subject to specimen viability): Preferred transport in equal parts RPMI. Lymphoid tissue: Transport in RPMI. FFPE tissue: no decalcifi cation. Tech-only: 3 days With interpretation: 5 days Computer assisted: (x5) Manual: (x5) or Tech-only (TC) CLIENT SERVICES 13

18 CYTOGENETICS AML FISH Profile Assessment uses RUNX1T1/RUNX1 t(8;21), PML/RARA t(15;17), RARA (17q21), MYH11/CBFB or CBFB inv(16), MLL (11q23) for determination of acute myeloid leukemia. Fluorescent in situ hybridization (FISH) Peripheral blood: 5-6 ml in sodium heparin (green-top) tube. Bone marrow: 2-3 ml in sodium heparin (green-top) tube. Bodily fluids: Bodily fluids for diagnostic testing of hematological cancers (subject to specimen viability): Preferred transport in equal parts RPMI. Lymphoid tissue: Transport in RPMI. FFPE tissue: no decalcification. Tech-only: 3 days With interpretation: 5 days Computer assisted: (x5) Manual: (x5) or Tech-only (TC) CLL FISH Profile Assessment uses 6q- (6p/6q21/6q23), ATM (11q22), +12 (12cen), 13q14/13q34, TP53 (17p13) for determination of chronic lymphocytic leukemia. Fluorescent in situ hybridization (FISH) Peripheral blood: 5-6 ml in sodium heparin (green-top) tube. Bone marrow: 2-3 ml in sodium heparin (green-top) tube. Bodily fluids: Bodily fluids for diagnostic testing of hematological cancers (subject to specimen viability): Preferred transport in equal parts RPMI. Lymphoid tissue: Transport in RPMI. Tech-only: 3 days With interpretation: 5 days Computer assisted: (x1) (x2) (x2) Manual: (x1) (x2) (x2) or Tech-only (TC) 14 GO.GENOPTIX.COM ONLINE ORDERING AND REPORTING PORTAL

19 GENOPTIX TESTING DIRECTORY CYTOGENETICS CML FISH Profile Assessment uses BCR-ABL/ASS1 t(9;22), +8 (8cen), RARA (17q21) for determination of chronic myeloid leukemia and chromic myeloid leukemia in transformation. Fluorescent in situ hybridization (FISH) Peripheral blood: 5-6 ml in sodium heparin (green-top) tube. Bone marrow: 2-3 ml in sodium heparin (green-top) tube. Bodily fl uids: Bodily fl uids for diagnostic testing of hematological cancers (subject to specimen viability): Preferred transport in equal parts RPMI. Lymphoid tissue: Transport in RPMI. FFPE tissue: no decalcifi cation (except for centromere as well as locus specifi c FISH probes) Tech-only: 3 days With interpretation: 5 days Computer assisted: (x1) (x1) (x1) Manual: (x1) (x1) (x1) ifish Profile Assessment uses CKS1B/CDKN2C (1p/1q), D5S630, D5S2064/EGR1 (5p/5q), 13q14/13q34, TP53 (17p13), IGH/FGFR3 t(4;14), IGH/CCND1 t(11;14), IGH/MAF t(14;16) on enriched CD138 plasma cells for determination of plasma cell disorders. Fluorescent in situ hybridization (FISH) Bone marrow: Preferred 2 ml in sodium heparin (green-top) tube. 5 days Computer assisted: (x1) (x6) TC (x1) Manual: (x1) (x6) TC (x1) or Tech-only (TC) or Tech-only (TC) CLIENT SERVICES 15

20 CYTOGENETICS MDS FISH Profile (Standard) Assessment uses D5S630, D5S2064/EGR1 (5p/5q), D7S486 (7p11 or 7cen/ 7q31), +8 (8cen), D20S108 (20q) for determination of myelodysplastic syndrome. Fluorescent in situ hybridization (FISH) Peripheral blood: 5-6 ml in sodium heparin (green-top) tube. Bone marrow: 2-3 ml in sodium heparin (green-top) tube. Bodily fluids: Bodily fluids for diagnostic testing of hematological cancers (subject to specimen viability): Preferred transport in equal parts RPMI. Lymphoid tissue: Transport in RPMI. FFPE tissue: no decalcification (except for centromere as well as locus specific FISH probes). Tech-only: 3 days With interpretation: 5 days Computer assisted: (x1) (x1) (x2) Manual: (x1) (x1) (x2) or Tech-only (TC) MDS FISH Profile (Extended) Assessment uses D5S630, D5S2064/EGR1 (5p/5q), D7S486 ((7p11 or 7cen/ 7q31), +8 (8cen), MLL (11q23), ETV6 (12p13), TP53 and D20S108 (20q) for determination of myelodysplastic syndrome. Fluorescent in situ hybridization (FISH) Peripheral blood: 5-6 ml in sodium heparin (green-top) tube. Bone marrow: 2-3 ml in sodium heparin (green-top) tube. Bodily fluids: Bodily fluids for diagnostic testing of hematological cancers (subject to specimen viability): Preferred transport in equal parts RPMI. Lymphoid tissue: Transport in RPMI. FFPE tissue: no decalcification (except for centromere as well as locus specific FISH probes). Tech-only: 3 days With interpretation: 5 days Computer assisted: (x1) (x2) (x4) Manual: (x1) (x2) (x4) or Tech-only (TC) 16 GO.GENOPTIX.COM ONLINE ORDERING AND REPORTING PORTAL

21 GENOPTIX TESTING DIRECTORY CYTOGENETICS MPN - Eosinophilia FISH Profile Assessment uses PDGFR-alpha (4q12), PDGFR-beta (5q32), FGFR1 (8p11) for determination of eosinophilia. Fluorescent in situ hybridization (FISH Peripheral blood: 5-6 ml in sodium heparin (green-top) tube. Bone marrow: 2-3 ml in sodium heparin (green-top) tube. Bodily fl uids: Bodily fl uids for diagnostic testing of hematological cancers (subject to specimen viability): Preferred transport in equal parts RPMI. Lymphoid tissue: Transport in RPMI. FFPE tissue: no decalcifi cation. Tech-only: 3 days With interpretation: 5 days Computer assisted: (x3) Manual: (x3) or Tech-only (TC) MPN FISH Profile Assessment uses BCR/ABL1/ASS1 t(9;22), CKS1B/ CDKN2C (1p/1q), D5S630, D5S2064/EGR1 (5p/5q), D7S486 (7p11 or 7cen/ 7q31), +8 (8cen), 13q14/13q34, and D20S108 (20q) for determination of myeloproliferative neoplasms. Fluorescent in situ hybridization (FISH) Peripheral blood: 5-6 ml in sodium heparin (green-top) tube. Bone marrow: 2-3 ml in sodium heparin (green-top) tube. Bodily fl uids: Bodily fl uids for diagnostic testing of hematological cancers (subject to specimen viability): Preferred transport in equal parts RPMI. Lymphoid tissue: Transport in RPMI. FFPE tissue: no decalcifi cation (except for centromere as well as locus specifi c FISH probes). Tech-only: 3 days With interpretation: 5 days Computer assisted: (x1) (x1) (x5) Manual: (x1) (x1) (x5) or Tech-only (TC) CLIENT SERVICES 17

22 CYTOGENETICS Myeloma FISH Profile Assessment uses CKS1B/CDKN2C (1p/1q), D5S630, D5S2064/EGR1 (5p/5q), 13q14/13q34, TP53 (17p13), IGH/ FGFR3 t(4;14), IGH/CCND1 t(11;14), IGH/MAF t(14;16) for determination of plasma cell disorders. Fluorescent in situ hybridization (FISH) Peripheral blood: 5-6 ml in sodium heparin (green-top) tube. Bone marrow: 2-3 ml in sodium heparin (green-top) tube. Bodily fluids: Bodily fluids for diagnostic testing of hematological cancers (subject to specimen viability): Preferred transport in equal parts RPMI. Lymphoid tissue: Transport in RPMI. FFPE tissue: no decalcification (except for centromere as well as locus specific FISH probes). Tech-only: 3 days With interpretation: 5 days Computer assisted: (x1) (x6) Manual: (x1) (x6 NHL FISH Profile Assessment uses BCL6 (3q27), 6q21/6q23, MYC (8q24), IGH/CCND1 t(11;14), IGH/BCL2 t(14;18), MALT1 (18q21) for determination of lymphoma subtypes. Fluorescent in situ hybridization (FISH) Peripheral blood: 5-6 ml in sodium heparin (green-top) tube. Bone marrow: 2-3 ml in sodium heparin (green-top) tube. Bodily fluids: Bodily fluids for diagnostic testing of hematological cancers (subject to specimen viability): Preferred transport in equal parts RPMI. Lymphoid tissue: Transport in RPMI. FFPE tissue: no decalcification (except for centromere as well as locus specific FISH probes). Tech-only: 3 days With interpretation: 5 days Computer assisted: (x6) Manual: (x6) or Tech-only (TC) or Tech-only (TC) 18 GO.GENOPTIX.COM ONLINE ORDERING AND REPORTING PORTAL

23 GENOPTIX TESTING DIRECTORY CYTOGENETICS UroVysion Detection of aneuploidy for chromosomes 3, 7, 17, and loss of the 9p locus via fl uorescent in situ hybridization (FISH) in urine specimens from patients with hematuria suspected of having urothelial cancers. Fluorescent in situ hybridization (FISH) Voided urine: 33 ml voided urine should be collected at the physicians offi ce. Mix voided urine 2:1 (v:v) with preservative. Recommended preservatives are Carbowax (2% polyethylene glycol in 50% ethanol) or PreservCyt. Transport in 50 ml centrifuge tube(s) or other tightly capped plastic container. Use ice pack for transport within 24 hours after collection. 10 days (x1) UroVysion is a registered trademark of Abbott Laboratories. Carbowax is a trademark The Dow Chemical Company. PreservCyt is a registered trademark of Hologic Inc CLIENT SERVICES 19

24 FLOW CYTOMETRY Intelligent Flow Profile (Blood or Bone Marrow) A 24-marker profile, with additional rational marker selection for phenotyping (up to 40 total antibodies). An evaluation of specimen adequacy and cellular integrity will also be performed. Markers include CD2, CD3, CD4, CD5, CD7, CD8, CD10, CD11b, CD13, CD14, CD16, CD19, CD20, CD23, CD33, CD34, CD38, CD45, CD56, CD64, CD117, Kappa, Lambda, HLA-DR. Flow cytometry Peripheral blood: 5-6 ml in sodium heparin (green-top) tube.. EDTA is acceptable. Acid-citrate-dextrose (ACD) unacceptable. Bone marrow aspirate: 2-3 ml in sodium heparin (green-top) tube. Bone marrow core: 1-2 cm minimum core length in RPMI. Acceptable alternative (Subject to viability): Fluids: Equal parts RPMI and specimen Transport to lab ASAP. Tech only: hours With interpretation: hours Tech-only: (x1) (xn) With interpretation: (x1) (xn) (x1) Intelligent Flow Profile (Fresh Tissue) An 18-marker profile, with additional rational marker selection for phenotyping (up to 40 total antibodies). An evaluation of specimen adequacy and cellular integrity will also be performed. Markers include CD2, CD3, CD4, CD5, CD7, CD8, CD10, CD13, CD14, CD19, CD20, CD23, CD34, CD38, CD45, CD56, Kappa, Lambda. Flow cytometry Fresh, unfixed tissue: 0.2 cm minimum in RPMI. Fine needle aspiration (FNA): Equal parts RPMI and specimen. Acceptable alternative (Subject to viability): Bronchial brushings / Bronchial washings. Transport to lab ASAP. Tech only: hours With interpretation: hours Tech-only: (x1) (xn) With interpretation: (x1) (xn) (x1) or Tech-only (TC) or Tech-only (TC) 20 GO.GENOPTIX.COM ONLINE ORDERING AND REPORTING PORTAL

25 GENOPTIX TESTING DIRECTORY FLOW CYTOMETRY Acute Leukemia Panel (Add-on) Available as an add-on with an intelligent Flow Profi le. Assessment uses MPO, CD79a, CD3, CD34, TDT, CD45, CD22, CD41, CD71a, CD235a, CD61 for further evaluation/determination of ambiguous acute leukemia. Flow cytometry Peripheral blood: 5-6 ml in sodium heparin (green-top) tube. Acid-citrate-dextrose (ACD) unacceptable. Bone marrow: 2-3 ml in sodium heparin (green-top) tube. Tech only: hours With interpretation: hours Additional (x7) when added to Intelligent Flow Profi le or Tech-only (TC) B-ALL MRD Profile Acute Lymphoblastic Leukemia with Minimal Residual Disease (ALL MRD). Available as a global test only. Markers include CD123, CD45, CD19, CD34, CD38, CD10, CD22, CD58, CD66C, CD9, CD13, CD33, CD20. Flow cytometry Acceptable: Peripheral blood: 3 x 5-6 ml in sodium heparin (green-top) tube. Bone marrow aspirate: 3 ml in sodium heparin (green-top) tube. Unacceptable: Lithium heparin (red-top) tube. Transport to lab ASAP hours (x1) (x12) (x1) Laboratory developed test (LDT CLIENT SERVICES 21

26 FLOW CYTOMETRY B-Cell Clonality (Add-on) Available as an add-on with an intelligent Flow Profile. Assessment uses ckappa, clambda, CD5, CD19, CD10, CD11c, CD19, CD20 for evaluation of the presence of monoclonal B-cell population with equivocal, nonspecific or absent expression of surface light chains. Flow cytometry Peripheral blood: 5-6 ml in sodium heparin (green-top) tube. EDTA also acceptable. Acid-citrate-dextrose (ACD) unacceptable. Bone marrow: 2-3 ml in sodium heparin (green-top) tube. Fresh, unfixed tissue: 0.2 cm minimum in RPMI Fine needle aspirate (FNA): Equal parts RPMI and specimen Transport to lab ASAP. Tech only: hours With interpretation: hours Additional (x3) when added to Intelligent Flow Profile CLL MRD Profile Chronic Lymphocytic Leukemia with Minimal Residual Disease (CLL MRD). Available as a global test only. Markers include CD3, CD5, CD19, CD20, CD22, CD43, CD79b, CD81. Flow cytometry Peripheral blood: 5-6 ml in sodium heparin (green-top) tube. EDTA is also acceptable. Acid-citrate-dextrose (ACD) is unacceptable. Bone marrow aspirate: 1mL with a minimum of 1 million cells. Do NOT fix. Preferred sample in sodium heparin (required if Cytogenetics is also performed), EDTA is acceptable. All others not acceptable. Transport to lab ASAP hours (x1) (x7) (x1) or Tech-only (TC) 22 GO.GENOPTIX.COM ONLINE ORDERING AND REPORTING PORTAL

27 GENOPTIX TESTING DIRECTORY FLOW CYTOMETRY LGL Panel (Add-on) Available as an add-on with an intelligent Flow Profi le. Assessment uses CD3, CD4, CD5, CD8, CD16, CD45, CD56, CD57, TA/B, TG/D, for determination of lymphomas to defi ne/evaluate large granular lymphocytes (LGL) and T-cell disorders. Flow cytometry Peripheral blood: 5-6 ml in sodium heparin (green-top) tube. EDTA is acceptable. Acit-citrate-dextrose (ACD) is unacceptable. Bone marrow: 2-3 ml in sodium heparin (green-top) tube. Transport to lab ASAP. Tech-only: hours With interpretation: hours Additional (x3) when added to immunophenotyping profi le or Tech-only (TC) Mature B-Cell Panel (Add-on) Available as an add-on with an intelligent Flow Profi le. Assessment uses CD5, CD11c, CD19, CD20, CD22, CD25, CD45, CD103, FMC7 for determination of B-cell disorders. Flow cytometry Peripheral blood: 5-6 ml in sodium heparin (green-top) tube. EDTA is acceptable. Acid-citrate-dextrose (ACD) is unacceptable. Bone marrow: 2-3 ml in sodium heparin (green-top) tube. Fresh, unfi xed tissue: 0.2 cm minimum in RPMI. Fine needle aspirate (FNA): Equal parts RPMI and specimen. Transport to lab ASAP. Tech-only: hours With interpretation: hours Additional (x5) when added to Intelligent Flow Profi le or Tech-only (TC) CLIENT SERVICES 23

28 FLOW CYTOMETRY Myeloma MRD Profile Available as a global test only. Markers include CD19, CD20, CD27, CD38, CD45, CD56, CD117, CD138, ckappa, clambda. Flow cytometry Bone marrow: 2-3 ml in sodium heparin (green-top) tube. Transport to lab ASAP hours (x1) (x9) (x1) Myeloma Panel (Add-on) Available as an add-on with an intelligent Flow Profile. Assessment uses CD19, CD27, CD28, CD38, CD45, CD56, CD81, CD138, CD117, CD200, ckappa, clambda for determination of plasma cell disorders. Flow cytometry Peripheral blood: 5-6 ml in sodium heparin (green-top) tube. EDTA is acceptable. Acid-citrate-dextrose (ACD) is unacceptable. Bone marrow: 2-3 ml in sodium heparin (green-top) tube. Transport to lab ASAP. Tech-only: hours With interpretation: hours Additional (x7) when added to immunophenotyping profile or Tech-only (TC) 24 GO.GENOPTIX.COM ONLINE ORDERING AND REPORTING PORTAL

29 GENOPTIX TESTING DIRECTORY FLOW CYTOMETRY PNH Evaluation Paroxysmal Nocturnal Hemoglobunuria (PNH) assessment uses gating antibodies CD235a, CD15, CD64 and CD45; and antibodies to GPI-linked antigens CD14 (monocytes), CD24 (granulocytes) and CD59 (erythrocytes) and FLAER (monocytes and granulocytes). Flow cytometry Peripheral blood: 5-6 ml in EDTA (purple-top) tube. Sodium heparin (green-top) tube is also acceptable. Transport to lab ASAP hours (x1) (x7) (x1) CLIENT SERVICES 25

30 MOLECULAR ABL1 Kinase Domain Mutation Detection of mutations in the ABL1 kinase domain for patients with BCR-ABL1 positive CML or ALL. RNA is isolated, reverse transcribed to complementary DNA (cdna), and the DNA sequence of targeted regions of ABL (exons 4, 6-7) is determined using next-generation sequencing (NGS) technology. Amplicon-based, next-generation sequencing (NGS) Peripheral blood: 2-3 ml in EDTA (purple-top) tube. Bone marrow: 2-3 ml in EDTA (purple-top) tube days (x1) MEDICARE MOLDX CPT CODE (x1) MOLDX Z CODE ZBX5N AML Molecular Profile Detection of mutations in key genes recurrently mutated in acute myeloid leukemia. Genomic DNA is isolated from Bone marrow aspirates or peripheral blood and the DNA sequence of targeted regions of the ASXL1, BCOR, CEBPA, CSF3R, DNMT3A, EZH2, IDH1, IDH2, KIT, KRAS, NPM1, NRAS, PHF6, PTPN11, RAD21, RUNX1, SF3B1, SRSF2, STAG2, TET2, TP53, U2AF1, WT1, and ZRSR2 genes is determined using next-generation sequencing (NGS) technology. Capture-based, next-generation sequencing (NGS) Peripheral blood: 2-3 ml in EDTA (purple-top) tube. Bone marrow: 2-3 ml in EDTA (purple-top) tube days (x1) MOLDX Z CODE ZB0T9 26 GO.GENOPTIX.COM ONLINE ORDERING AND REPORTING PORTAL

31 GENOPTIX TESTING DIRECTORY MOLECULAR B-Cell Clonality Assessment Detection of clonal B-cell immunoglobulin heavy chain (IGH) gene rearrangement by polymerase chain reaction (PCR) of variable and joining regions on chromosome 14. Polymerase chain reaction (PCR) Peripheral blood: 2-3 ml in EDTA (purple-top) tube. Bone marrow: 2-3 ml in EDTA (purple-top) tube. 7 days (x1) MOLDX Z CODE ZB3PK CALR Mutation Analysis The DNA sequence of targeted regions of the CALR gene exon 9 is determined using amplicon-based, next-generation sequencing (NGS) technology. Amplicon-based, next-generation sequencing (NGS) Peripheral blood: 2-3 ml in EDTA (purple-top) tube. Bone marrow: 2-3 ml in EDTA (purple-top) tube. 9 days (x1) MEDICARE CPT CODE (x1) MOLDX Z CODE ZB08A CLIENT SERVICES 27

32 MOLECULAR CLL Comprehensive Profile Detection of mutations in key genes recurrently mutated in chronic lymphocytic leukemia (CLL) malignancies. Genomic DNA is isolated from bone marrow aspirates or peripheral blood and the DNA sequence of targeted regions of the ASXL1, ATM, BCOR, BIRC3, BRAF, BTK, CCND1, CCND2, CDKN2A, CDKN2B, DDX3X, DNMT3A, FAT1, FBXW7, HIST1H1E, IKZF3, IRAK4, ITPKB, KRAS, MAP2K1, MAP3K14, MAPK1, MED12, MEF2B, MYD88, NFKBIE, NOTCH1, NRAS, PLCG2, PIK3CD, POT1, PTEN, RB1, RIPK1, RPS15, SAMHD1, SETD2, SF3B1, SPEN, SPOP, TET2, TLR2, TP53, TRAF2, TRAF3, UBR5, XPO1 and ZMYM3 genes is determined using next-generation sequencing (NGS) technology. Capture-based, next-generation sequencing (NGS) Peripheral blood: 2-3 ml in EDTA (purple-top) tube. Bone marrow: 2-3 ml in EDTA (purple-top) tube. Unacceptable: Specimens received fixed in alternative fixation methods. Decalcified, frozen or fresh tissue days (x1) In addition to the CPT code(s) referenced, a microdissection service, CPT code (x1), may be medically indicated and separately billed when performing molecular diagnostic testing on solid tumor specimens. MOLDX Z CODE ZB4BK CLL Targeted Profile Detection of mutations in key genes recurrently mutated in CLL. Genomic DNA is isolated and the DNA sequence of targeted regions of the ATM, BIRC3, NOTCH1, SF3B1, and TP53 genes is determined using next-generation sequencing (NGS) technology. Capture-based, next-generation sequencing (NGS) Peripheral blood: 2-3 ml in EDTA (purple-top) tube. Bone marrow: 2-3 ml in EDTA (purple-top) tube. Unacceptable: Specimens received fixed in alternative fixation methods. Decalcified, frozen or fresh tissue days (x1) In addition to the CPT code(s) referenced, a microdissection service, CPT code (x1), may be medically indicated and separately billed when performing molecular diagnostic testing on solid tumor specimens. MOLDX Z CODE ZB3HZ 28 GO.GENOPTIX.COM ONLINE ORDERING AND REPORTING PORTAL

33 GENOPTIX TESTING DIRECTORY MOLECULAR KIT (D816V) Mutation Analysis KIT mutations are present in the majority of cases of mast cell disease/systemic mastocytosis. Patient DNA is isolated and subjected to allele-specifi c polymerase chain reaction (PCR) amplifi cation. Polymerase chain reaction (PCR) Peripheral blood: 2-3 ml in EDTA (purple-top) tube. Bone marrow: 2-3 ml in EDTA (purple-top) tube days (x1) MOLDX Z CODE ZB2P CLIENT SERVICES 29

34 MOLECULAR FLT3 Mutation Analysis - ITD/TKD Internal Tandem Duplication (ITD) and Tyrosine Kinase Domain (TKD). FLT3 ITD and TKD regions are analyzed by polymerase chain reaction (PCR) and fluorescent fragment size analysis. The signal ratio of the FLT3 ITD region compares the signal intensity of the mutation to the wild-type. Polymerase chain reaction (PCR) Peripheral blood: 2-3 ml in EDTA (purple-top) tube. Bone marrow: 2-3 ml in EDTA (purple-top) tube days (x1) for ITD (x1) for TKD FLT3/NPM1 Mutation Analysis FLT3 ITD and TKD regions are analyzed by polymerase chain reaction (PCR) and fluorescent fragment size analysis. Exon 12 of NPM1 is analyzed by PCR to detect small insertion mutations specific to AML. Polymerase chain reaction (PCR) Peripheral blood: 2-3 ml in EDTA (purple-top) tube. Bone marrow: 2-3 ml in EDTA (purple-top) tube days (x1) 30 GO.GENOPTIX.COM ONLINE ORDERING AND REPORTING PORTAL

35 GENOPTIX TESTING DIRECTORY MOLECULAR GenoTRACE Quantitative BCR-ABL Quantitative real-time polymerase chain reaction (PCR) is used for the detection of t(9;22) BCR-ABL1 fusion transcripts that result in p190, p210, or p230 fusion proteins. Minimal residual disease monitoring results for the major (p210 fusions) are reported and graphed on the IS scale. Monitoring results for the minor and micro fusion breakpoints are reported. Polymerase chain reaction (PCR) Peripheral blood: 2-3 ml in EDTA (purple-top) tube. Bone marrow: 2-3 ml in EDTA (purple-top) tube. 4 days (xn) major breakpoints (xn) minor breakpoints (xn) other breakpoints MEDICARE MOLDX CPT CODE (x1) MOLDX Z CODE ZB0CC IgVH Hypermutation Analysis Somatic hypermutation of the IGH V region occurs naturally during B-cell maturation in lymphoid follicles. DNA sequencing of the amplifi ed IGH gene variable (V) region is performed and is compared to the germline (unmutated) consensus sequence. In CLL patients, a clonal B-cell population with a hypermutated IgH V region (greater than 2% of DNA nucleotides different from the reference germline sequence) suggests a more mature malignancy and correlates with a more favorable prognosis and a signifi cantly longer median survival time than those with unmutated (less than or equal to 2% difference) IgH V region. Sanger Sequencing Peripheral blood: 2-3 ml in EDTA (purple-top) tube. Bone marrow: 2-3 ml in EDTA (purple-top) tube. 8 days (x1) MOLDX Z CODE ZB089 GenoTRACE i s a registred trademark of Genoptix, Inc CLIENT SERVICES 31

36 MOLECULAR JAK2 Exon 12/13 JAK2 encodes for a protein tyrosine kinase involved in activated signaling. Genomic DNA is isolated from bone marrow aspirates or peripheral blood and the DNA sequences of JAK2 exons are determined using next-generation sequencing technology. Amplicon-based, next-generation sequencing (NGS) Peripheral blood: 2-3 ml in EDTA (purple-top) tube. Bone marrow: 2-3 ml in EDTA (purple-top) tube. 9 days (x1) MEDICARE CPT CODE (x1) MOLDX Z CODE ZB08A JAK2 V617F Mutation Analysis JAK2 mutation analysis to determine the presence of the V617F (1849G>T) mutation. Polymerase chain reaction (PCR) Peripheral blood: 2-3 ml in EDTA (purple-top) tube. Bone marrow: 2-3 ml in EDTA (purple-top) tube. 4 days (x1) MOLDX Z CODE ZB3PL 32 GO.GENOPTIX.COM ONLINE ORDERING AND REPORTING PORTAL

37 GENOPTIX TESTING DIRECTORY MOLECULAR Lymphoid Molecular Profile Detection of mutations in key genes recurrently mutated in lymphoid malignancies. Genomic DNA is isolated from bone marrow aspirates, peripheral blood, or tissue and the DNA sequence of targeted regions of the ABL1, ABL2, ALK, ARHGEF1, ARID1A, ARID2, ASXL1, ATM, B2M, BCL2, BCL6, BCOR, BIRC3, BRAF, BTK, CARD11, CCND1, CND2, CCND3, CD274, CD79A, CD79B, CDKN1B, CDKN2A, CDKN2B, CIITA, CREBBP, CRLF2, CSF1R, CTCF, CTNNB1, CXCR4, DDX3X, DIS3, DNMT3A, EBF1, EGR1, EP300, EPOR, ETV6, EZH2, FAM46C, FAS, FAT1, FBXW7, FGFR3, FOXO1, GATA3, GNA13, GNAI2, HIST1H1E, HRAS, ID3, IDH1, IDH2, IKBKB, IKZF1, IKZF3, IRAK4, ITPKB, JAK1, JAK2, JAK3, KLF2, KMT2D, KRAS, MALT1, MAP2K1, MAP3K14, MAPK1, MED12, MEF2B, MYC, MYCN, MYD88, NF1, NFKBIE, NOTCH1, NOTCH2, NOTCH3, NRAS, NT5C2, P2RY8, PDGFRB, PHF6, PIK3CA, PIK3CD, PIK3R1, PIM1, PLCG1, PLCG2, POT1, PPM1D, PRDM1, PRPS1, PTEN, PTPN11, RB1, REL, RHOA, RIPK1, RPS15, RUNX1, S1PR2, SAMHD1, SETD2, SF3B1, SGK1, SH2B3, SOCS1, SPEN, STAT3, STAT5B, STAT6, TBL1XR1, TCF3, TET2, TLR2, TNFAIP3, TNFRSF14, TP53, TRAF2, TRAF3, UBR5, WT1, XPO1, ZFHX4, and ZMYM3 genes is determined using next-generation sequencing (NGS) technology. Capture-based, next-generation sequencing (NGS) Peripheral blood: 2-3 ml in EDTA (purple-top) tube. Bone marrow: 2-3 ml in EDTA (purple-top) tube. Tissue: Two (2) formalin-fi xed, paraffi n-embedded tissue/ fi ne needle aspirate (FFPE/FNA) blocks containing tumor tissue from recent surgery or biopsy or sixteen (16) 2x5 µm sections with accompanying H&E slide. Acceptable Alternative: One (1) formalin-fi xed, paraffi n-embedded tissue/fi ne needle aspirate (FFPE/FNA) block containing tumor tissue from recent surgery or biopsy or eight (8) 2 5 µm sections with accompanying H&E slide days (x1) In addition to the CPT code(s) referenced, a microdissection service, CPT code (x1), may be medically indicated and separately billed when performing molecular diagnostic testing on solid tumor specimens. MOLDX Z CODE ZB0T CLIENT SERVICES 33

38 MOLECULAR MLL-PTD Mutation Analysis The presence of MLL partial tandem duplications (PTD) between exons 2 and 8 in the MLL (mixed lineage leukemia) gene is detected. Polymerase chain reaction (PCR) Peripheral blood: 2-3 ml in EDTA (purple-top) tube. Bone marrow: 2-3 ml in EDTA (purple-top) tube. 8 days (x1) MOLDX Z CODE ZBZW4 MPL Mutation Analysis MPL encodes for the thrombopoietin receptor, an important growth and survival factor for megakaryocytes. Genomic DNA is isolated from bone marrow aspirates or peripheral blood, and the DNA sequence of exon 10 including W515L/K and S505 is determined using next-generation sequencing (NGS) technology. Amplicon-based, next-generation sequencing (NGS) Peripheral blood: 2-3 ml in EDTA (purple-top) tube. Bone marrow: 2-3 ml in EDTA (purple-top) tube. 9 days (x1) MEDICARE CPT CODE (x1) MOLDX Z CODE ZB08A 34 GO.GENOPTIX.COM ONLINE ORDERING AND REPORTING PORTAL

39 GENOPTIX TESTING DIRECTORY MOLECULAR MPN Targeted Profile Detection of mutations in key genes recurrently mutated in MPNs. Genomic DNA is isolated and the DNA sequence of targeted regions of the CALR, CSF3R, JAK2, MPL and SETBP1 genes is determined using next generation sequencing technology. Amplicon-based, next-generation sequencing (NGS) Peripheral blood: 2-3 ml in EDTA (purple-top) tube. Bone marrow: 2-3 ml in EDTA (purple-top) tube days (x1) MOLDX Z CODE ZB08A Myeloid Molecular Profile Detection of mutations in key genes recurrently mutated in myeloid malignancies. Genomic DNA is isolated from bone marrow aspirates or peripheral blood and the DNA sequence of targeted regions of the ASXL1, BCOR, BRAF, CALR, CBL, CEBPA, CSF3R, DDX41, DNMT3A, ETNK1, ETV6, EZH2, GATA2, GNAS, GNB1, IDH1, IDH2, JAK2, KIT, KRAS, MPL, NF1, NPM1, NRAS, PDGFRA, PHF6, PPM1D, PTPN11, RAD21, RUNX1, SETBP1, SF3B1, SH2B3, SMC1A, SMC3, SRSF2, STAG2, STAT3, STAT5B, TET2, TP53, U2AF1, WT1, ZRSR2 genes is determined using next-generation sequencing (NGS) technology. Capture-based, next-generation sequencing (NGS) Bone marrow: 2-5 ml in EDTA (purple-top) tube. Peripheral blood: 2-5 ml in EDTA (purple-top) tube. Acceptable alternative: Bone marrow: 2-3 ml in sodium heparin (green-top) tube. Peripheral blood: 2-3 ml in Sodium Heparin (green-top) tube. Unacceptable: Specimens received fi xed in alternative fi xation methods. Decalcifi ed, frozen or fresh tissue days (x1) MOLDX Z CODE ZB0TB CLIENT SERVICES 35

40 MOLECULAR PML/RARA Quantitative Analysis Reverse transcriptase polymerase chain reaction (RT- PCR) for quantitative detection of t(15;17) PML/RARA, a recurrent genetic abnormality found in a subset of patients with acute promyelocytic leukemia (APL). This RNA-based test detects all three gene fusion patterns: type A (short, S-form, bcr-3), type B (long, L-form, bcr-1), and type B variant (variable, V-form, bcr-2). Polymerase chain reaction (PCR) Peripheral blood: 2-3 ml in EDTA (purple-top) tube. Bone marrow: 2-3 ml in EDTA (purple-top) tube days (x1) MOLDX Z CODE ZB1HT T-Cell Clonality Assessment (Beta) Polymerase chain reaction (PCR) allows discrimination of individual members of the sufficiently diverse TCR- Beta gene family. By using PCR amplification of the Beta chain of the T-cell receptor (TCR-Beta) a dominant clone can be identified in over 90% of T-cell malignancies. Polymerase chain reaction (PCR) Peripheral blood: 2-3 ml in EDTA (purple-top) tube. Bone marrow: 2-3 ml in EDTA (purple-top) tube. 7 days (x1) MOLDX Z CODE ZB07L 36 GO.GENOPTIX.COM ONLINE ORDERING AND REPORTING PORTAL

41 GENOPTIX TESTING DIRECTORY MOLECULAR T-Cell Clonality Assessment (Gamma) Polymerase chain reaction (PCR) allows discrimination of individual members of the suffi ciently diverse TCR-Gamma gene family. PCR-based analysis using oligonucleotide consensus primers specifi c for the T-cell receptor Gamma gene variable and joining regions on chromosome 7. Polymerase chain reaction (PCR) Peripheral blood: 2-3 ml in EDTA (purple-top) tube. Bone marrow: 2-3 ml in EDTA (purple-top) tube days (x1) MOLDX Z CODE ZB2DU CLIENT SERVICES 37

42 SOLID TUMOR CYTOGENETICS IMMUNOHISTOCHEMISTRY CYTOGENETICS IMMUNOHISTOCHEMISTRY FLOW CYTOMETRY MOLECULAR MOLECULAR H&E STAIN ON MELANOMA