NeoTYPE Cancer Profiles 30+ Multimethod Assays for Hematologic Diseases and Solid Tumors Molecular FISH Anatomic Pathology The next generation of diagnostic, prognostic, and therapeutic assessment
What are NeoTYPE Cancer Profiles? These are multi-method test panels based on next-gen sequencing and identify the genetic changes most significant for: Confirming diagnosis Disease classification Assessing prognosis Predicting response to therapy Identifying new therapeutic approaches Identifying clinical trial opportunities When to Test? These Profiles highlight high-frequency recurrent mutations and provide a practical approach to understanding the cancer s biology for the most effective patient management. Tests are appropriate for: First-line gene testing Patients with an unusual clinical presentation Developing therapeutic strategies Identifying clinical trials Patients resistant to conventional therapy Focus on Immuno-Oncology for Solid Tumors Tumor Mutation Burden testing is now a standard component of the Discovery Profile, and can be added to any of the solid tumor Profiles (except Liposarcoma Fusion). MSI Instability Analysis is routinely performed with Colorectal, Endometrial, Esophageal, Gastric, GI Predictive, Ovarian, and Pancreas Profiles, and may be added to any other solid tumor Profile. Please note normal tissue is required for reference in MSI testing. Please send normal tissue adjacent to the tumor on the same block, a separate block, or a fresh blood specimen. PD-L1 PD-L1 22C3 IHC is performed with all solid tumor Profiles (except Liposarcoma Fusion). This test is indicated as an aid in identifying NSCLC patients for treatment with KEYTRUDA (pembrolizumab).* * 22C3 pharmdx [package insert]. Carpinteria, CA: Dako; P03951_04/SK00621-5/2016.10 2 NeoGenomics Laboratories
Benefits and Advantages of Targeted Profile Testing Targeted Test design is tailored to driver mutations in specific tumors. Actionable All genes have clinical significance when mutated. Comprehensive Unique reporting of diagnostic, prognostic, and therapeutic implications. Flexible Choose as-shown or add on. Efficient With fast TAT s, NeoTYPEs can replace first-line single-gene testing. Quantitative Reporting of mutant allele frequencies is useful for monitoring. Cost-effective Multiplexing with next-generation sequencing (NGS) can create savings compared to several single-gene orders. Performance, Flexibility, Selection Next-generation sequencing (NGS) is widely known for its high sensitivity which aids detection of abnormalities in small biopsies, minimal residual disease, and subclonal heterogeneity. With 31 choices of Profiles in the NeoTYPE suite, plus available add-ons, the wide variety of test options lets pathologists and oncologists optimize the match between specimen, target genes, and the patient s clinical needs. NeoTYPE Cancer Profiles simplify the laboratory testing process and provide key diagnostic, prognostic, and predictive information you need for up-to-date and fully informed decision-making. NeoGenomics Laboratories 3
Sample Report 4 NeoGenomics Laboratories
Broad Reach Hematologic Profiles Myeloid Disorders (54 Molecular) ABL1 ASXL1 ATRX BCOR BCORL1 CALR CBL CBLB CBLC CSF3R CUX1 DNMT3A ETV6 EZH2 FBXW7 GATA1 GATA2 GNAS IKZF1 KDM6A MLL MPL MYD88 PHF6 RAD21 RUNX1 SF3B1 SMC1A SMC3 SRSF2 STAG2 TET2 U2AF1 WT1 ZRSR2 Broad Reach Solid Tumor Profiles Precision (48 Molecular, 1 IHC) ABL1 ALK APC ATM CDH1 CSF1R FBXW7 GNA11 GNAQ GNAS HNF1A KDR MLH1 MPL RB1 RET SMARCB1 STK11 VHL Discovery (315 Genes + Tumor Mutation Burden + 9 FISH + ) Next-gen sequencing of 315 genes + Tumor Mutation Burden + 9 FISH +. This is an actionable discovery panel suitable for clinical research applications and wide-spectrum patient testing. See website or handout for complete test details. Cancer-Specific Hematologic Profiles AITL/Peripheral T-Cell Lymphoma Profile (5 Molecular) DNMT3A RHOA TET2 AML Favorable-Risk (2 Molecular) AML Prognostic (27 Molecular) ASXL1 BCOR CSF3R DNMT3A ETV6 EZH2 MLL PHF6 RUNX1 STAG2 TET2 WT1 CLL Prognostic (5 Molecular, 1 FISH Panel) IgVH Mutation MYD88 SF3B1 CLL FISH Panel JMML (15 Molecular) CBL Lymphoma (8 Molecular) BCL1 BCL2 CARD11 CD79B EZH2 MYD88 MDS/CMML (31 Molecular) ASXL1 BCOR BCORL1 CBL CUX1 DNMT3A ETV6 EZH2 RUNX1 SF3B1 SRSF2 STAG2 TET2 U2AF1 ZRSR2 MPN (24 Molecular) ABL1 ASXL1 CALR CSF3R EZH2 MPL SRSF2 TET2 U2AF1 NeoGenomics Laboratories 5
Cancer-Specific Solid Tumor Profiles Brain (37 Molecular, 7 FISH, 1 IHC) ATRX CDK6 CIC vlll Analysis FUBP1 H3F3A MGMT Promoter Methylation MYC MYCN NF1 NF2 PTCH1 RB1 SETD2 TERT Promoter 1p/19q Deletion FISH FISH FISH MYCN FISH Amp FISH FISH Breast (22 Molecular, 3 FISH, 1 IHC) BRCA1 BRCA2 FISH FISH Cervical (22 Molecular, 2 FISH, 1 IHC) FISH FISH Colorectal (24 Molecular, 2 FISH, 1 IHC) APC MLH1 Promoter Methylation FISH FISH Endometrial (21 Molecular, 2 FISH, 1 IHC) FISH FISH Esophageal (23 Molecular, 3 FISH, 1 IHC) FISH FISH Gastric (23 Molecular, 3 FISH, 1 IHC) FISH FISH GI Predictive Profile (5 Molecular, 1 FISH, 1 IHC) GIST (11 Molecular, 1 IHC) Head & Neck (25 Molecular, 2 FISH, 1 IHC) ATM RB HPV DNA Tissue Test FISH FISH Liposarcoma Fusion Profile (5 Molecular, 1 FISH) COL1A2-PLAG1 EWSR1-DDIT3 FUS-DDIT3 HMGA2-LPP LPP-HMGA2 MDM2 FISH 6 NeoGenomics Laboratories
Liver/Biliary (24 Molecular, 2 FISH, 1 IHC) ATM FISH FISH Lung (21 Molecular, 6 FISH, 1 IHC) Exon 14 Deletion Analysis ALK FISH FISH FISH RET FISH ROS1 FISH Melanoma (18 Molecular, 1 FISH, 1 IHC) GNA11 GNAQ TERT Promoter FISH Other Solid Tumor (24 Molecular, 2 FISH, 1 IHC) GNAS FISH FISH Ovarian (23 Molecular, 2 FISH, 1 IHC) BRCA1 BRCA2 FISH FISH Pancreas (25 Molecular, 3 FISH, 1 IHC) ARID1A BRCA1 BRCA2 PBRM1 VHL FISH FISH Soft Tissue (19 Molecular, 2 FISH, 1 IHC) GNAS FISH FISH Thyroid (16 Molecular, 2 FISH, 1 IHC) ALK RET TERT Promoter FISH RET FISH Options for Customization Add-Ons Tumor Mutation Burden may be added to any Solid Tumor Profile except Liposarcoma Fusion. is a standard component of the Discovery Profile. Any genes in the 48-gene Precision Profile for Solid Tumors may be added to any of the other Solid Tumor Profiles. Any genes in the 54-gene Myeloid Disorders Profile may be added to any of the Hematologic Diseases Profiles. Results of testing for added genes will be included in the comprehensive NeoTYPE report for that Profile. Tech-Only FISH This option is available to pathology clients who want to perform the professional components of any FISH tests within a Profile. NeoGenomics Laboratories 7
Ordering Information Specimen options: Peripheral blood Bone marrow aspirate Fresh tissue FFPE slides or block Please see website for test-specific details TAT: 10-22 days (varies by Profile) Billing: NeoGenomics offers institutional and third-party billing. New tests are in development. Sign up at neogenomics.com to be notified. NeoGenomics Laboratories is a specialized oncology reference laboratory providing the latest technologies, testing partnership opportunities, and interactive education to the oncology and pathology communities. We offer the complete spectrum of diagnostic services in molecular testing, FISH, cytogenetics, flow cytometry, and immunohistochemistry through our nation-wide network of CAP-accredited, CLIA-certified laboratories. Committed to research as the means to improve patient care, we provide Pharma Services for pharmaceutical companies, in vitro diagnostic manufacturers, and academic scientist-clinicians. We promote joint publications with our client physicians. NeoGenomics welcomes your inquiries for collaborations. Please contact us for more information. 12701 Commonwealth Dr., Suite 9 Fort Myers, FL 33913 Phone: 866.776.5907/ Fax: 239.690.4237 neogenomics.com 2018 NeoGenomics Laboratories, Inc. All Rights Reserved. All other trademarks are the property of their respective owners. Rev. 040618