ADVANCED STAINING PRODUCT CATALOG. In Situ Hybridization Probes Immunohistochemistry Antibodies Detection Systems Ancillary Reagents

Similar documents
In Situ Hybridization Immunohistochemistry

Single and Multiplex Immunohistochemistry

Protocols for Zytomed Systems antibodies on fully automated IHC staining systems date of issue: September 20, 2012

Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK

Applications of IHC. Determination of the primary site in metastatic tumors of unknown origin

C.L. Davis Foundation Descriptive Veterinary Pathology Course

Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK

Thermo Scientific UltraVision Quanto for Immunohistochemistry The New Generation Micro-Polymer Detection System

Pepsin Solution ready-to-use

IHC Panels as an Aid in Diagnostic Decision Making

NEW IHC A n t i b o d i e s

Workflow. Connecting the Pieces For Total Patient Care

The impact of proficiency testing on lab immunoassays

Technology from Abcam

The role of immunohistochemistry in surgical pathology of the uterine corpus and cervix

Charles Halsey, DVM, PhD, DACVP Pfizer, Inc. IHC Resources

Differential diagnosis of HCC

The Panel Approach to Diagnostics. Lauren Hopson International Product Specialist Cell Marque Corporation

Breast - ductal carcinoma CK7 ER PR GATA3 Mammaglobin (50-70%) GCDFP-15 (50-70%) E-cadherin HMWCK CK20 PAX2 ER/PR/HER2 on all newly diagnosed cases

IHC Reagents & Kits. CE/IVD Certified

Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK

LIST OF ORGANS FOR HISTOPATHOLOGICAL ANALYSIS:!! Neural!!!!!!Respiratory:! Brain : Cerebrum,!!! Lungs and trachea! Olfactory, Cerebellum!!!!Other:!

HSL-Advanced Diagnostics 2018 / 19 Test & Service List

Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK

Molecular Probes Introducing 14 new probes

Simultaneous de-waxing and standardisation of antigen retrieval in immunohistochemistry using commercially available equipment

Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK

Ascitic Fluid and Use of Immunocytochemistry. Mercè Jordà, University of Miami

HER2 CISH pharmdx TM Kit Interpretation Guide Breast Cancer

Descriptive Immunohistochemistry. Agenda. Agenda. What is Immunohistochemistry? 6/3/2014. Tissue from a dog

Bihong Zhao, M.D, Ph.D Department of Pathology

Instant Quality FISH. The name says it all.

Immunohistochemistry. Potential and challenges To be or not to be

Immunohistochemical classification of the unknown primary tumour (UPT) Part I. Prof. Mogens Vyberg NordiQC Institute of Pathology Aalborg, Denmark

Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK

IHC Polymer. BioGenex Website. Presented for: Presented by: Date: BioGenex Tech Support 2016

MT09 - Normal Human Tissue Microarray, FDA

Nordic Immunohistochemical Quality Control

Milestones in Her 2 Testing

LN04 - Lymphoma Tissue Microarray

Diagnostic BioSystems Anatomic Pathology Catalog. Affordable IHC Solutions

Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK

The unkown primary tumour: IHC Classification, antibody selection, protocol optimization, controls and EQA (part I)

Classification of the unknown primary tumour: the primary IHC panel

Immunohistochemical classification of lung carcinomas and mesotheliomas. Prof. Mogens Vyberg NordiQC Institute of Pathology Aalborg, Denmark

Estrogen receptor (ER)

Diagnostic IHC in lung and pleura pathology

Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK

In Situ Hybridization: Market Strategies and Forecasts, US,

INTRODUCTION TO PATHOLOGICAL TECHNIQUES. 1. Types of routine biopsy procedures 2. Special exams (IHC, FISH)

Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK

Nitta et al. Diagnostic Pathology 2012, 7:60

The unknown primary tumour: IHC classification part I, the primary panel - Antibody selection, protocol optimization, controls and EQA

Cutaneous metastases. Thaddeus Mully. University of California, San Francisco Professor, Departments of Pathology and Dermatology

Cancers of unknown primary : Knowing the unknown. Prof. Ahmed Hossain Professor of Medicine SSMC

Histopathological diagnosis of CUP

DOUBLE STAINS. Toll-Free: Direct:

October Billing and compliance. Coagulation. Immunohistochemistry. Immunology. Referral testing ICD 10

Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK

The unkown primary tumour: IHC Classification, antibody selection, protocol optimization, controls and EQA (part II)

Reporting of carcinoma of unknown primary tumour (CUP)

Gastric Carcinoma with Lymphoid Stroma: Association with Epstein Virus Genome demonstrated by PCR

(A) PCR primers (arrows) designed to distinguish wild type (P1+P2), targeted (P1+P2) and excised (P1+P3)14-

Role of immunohistochemistry in the differential diagnosis of malignant small round cell tumor: a study of 38 cases

Novocastra Liquid Mouse Monoclonal Antibody Myeloperoxidase

THYROID TUMOR DIAGNOSIS: MARKER OF THE MONTH CLUB

From Morphology to Molecular Pathology: A Practical Approach for Cytopathologists Part 1-Cytomorphology. Songlin Zhang, MD, PhD LSUHSC-Shreveport

Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK

microrna Presented for: Presented by: Date:

Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK

Lung Anaplastic Lymphoma Kinase (lu-alk)

Breast cancer: Antibody selection, protocol optimzation controls and EQA

INTERPRETATION OF IMMUNOHISTOCHEMICAL STAINS - DIFFICULTIES AND PITFALLS. Gabor Fischer Diagnostic Services Manitoba University of Manitoba

Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK

Cytokeratin 19 (CK19)

Assessment Run B HER2 IHC

SMH (Myosin, smooth muscle heavy chain)

Case: The patient is a 73 year old woman with vague complaints of dyspepsia and abdominal pain. Upper endoscopy showed features of gastritis and a

The clinically challenging entity of liver metastasis from tumors of unknown primary

Immunohistochemistry Research Products

Estrogen receptor (ER)

recommended for detecting myoepithelial cells.

TEST MENU BY SPECIALTY

Solutions for IHC. Immunohistochemistry Products 2018 Catalog

Immunohistochemistry and Bladder Tumours

External Quality Assessment of melanocytic marker analyses NordiQC experience

Assessment Run B HER2 IHC

Section 14 Other Cancers. Cancer of Unknown 113 Primary Site INTRODUCTION PATHOLOGIC EVALUATION

PRODUCT I N FOR MATION Fujirebio Diagnostics EIA Kit

Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK

Dr. dr. Primariadewi R, SpPA(K)

Bond Ready-to-Use Primary Antibody Progesterone Receptor (16)

CURRENT AND EMERGING CANCER DIAGNOSTIC TESTS Emerging Assays, and Companies Developing New Technologies and Products.

Thyroid transcription factor-1 (TTF1) Assessment run

IIImmunohistochemistry (IHC) Outreach Services

ACCURACY OF IMMUNOHISTOCHEMISTRY IN EVALUATION

Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK

Quality in Control. ROS1 Analyte Control. Product Codes: HCL022, HCL023 and HCL024

TUMOR M ARKERS MARKERS

Diagnostic BioSystems

Transcription:

2017 ADVANCED STAINING PRODUCT CATALOG In Situ Hybridization Probes Immunohistochemistry Antibodies Detection Systems Ancillary Reagents

A History of Delivering Superior Products Genemed a wholly-owned subsidiary of Sakura Finetek U.S.A., Inc. was founded in 1987 and is located in the center of the South San Francisco Biotechnology community. For over 25 years, Genemed has been providing outstanding contract development and manufacturing services for well-established pharmaceutical and diagnostic companies. At Genemed we incorporate quality from the inside out, from our dedicated employees and efficient operations to our finished products. We are FDA registered and ISO-13485:2003 certified. Every part of our facility, systems, and processes are continuously monitored to ensure that we meet the highest standards of quality and customer satisfaction. Mission Statement Genemed provides cancer and infectious disease advanced staining diagnostic reagents. We create smarter and user-friendly diagnostic tools and solutions by applying our expertise in product design and manufacturing processes. Genemed strives to go above and beyond to meet every customer need with our personalized service. We are passionate at applying innovative technology and breakthrough scientific discoveries to improve product quality and reliability which ensure accurate diagnoses and enhanced patient care. We pride ourselves in conducting business in a fair and ethical manner. Genemed values our employees by promoting a learning environment with professional growth.

TABLE OF CONTENTS 2 8 27 28 29 In Situ Hybridization New Product 2 Probes 3 Detection Kit 7 Ancillary Reagents 7 Immunohistochemistry Primary Antibodies 8 Detection Kits 24 Ancillary Reagents 26 International Distributors Index Product List by Name 28 Ordering Information

ISH - New Product HER2 Chromogenic In Situ Hybridization (CISH) Kit Genemed HER2 CISH Kit is intended to detect HER2 gene amplification in formalin-fixed, paraffin-embedded (FFPE) tissue sections using Chromogenic In Situ Hybridization. The human gene HER2, or c-erbb-2, and the rat equivalent gene, neu, have been identified as proto-oncogenes sharing homology with the closely related v-erbb oncogene. The HER2 gene is located on chromosome 17 (17q12-21) and encodes a 185 kda membrane receptor-like protein. HER2 has tyrosine kinase activity and shares homology with, but is distinct from, the epidermal growth factor receptor (known as EGFr, HER1, or c-erbb-1). Genemed HER2 Probe (Reagent C) is a double-stranded DNA probe that has been labeled with digoxigenin. It is supplied in a liquid format in hybridization buffer. It has been demonstrated to contain the HER2 gene by PCR, and to bind specifically to the HER2 gene locus on chromosome 17q12-21 by metaphase FISH in normal lymphocytes. No. of Tests: 20 (20 µl probe per test) : 80-0001 Intended Use: USA RUO, CE IVD CISH Advantages: a. Bright-field microscopy b. Morphology observable c. Quantitative interpretation d. Archivable results 2 IVD: In Vitro Diagnostic RUO: Research Use Only RTU: Ready-To-Use Concentrate Dilution: 1:100 unless indicated Application: Formalin-Fixed, Paraffin-Embedded

ISH - Probes In Situ Hybridization Probes Genemed CISH and FISH probes provide a practical method to detect gene aberration, including gene amplification, deletion, chromosome/gene copy number change, chromosome translocation, gene expression at RNA level, and viral/bacterial detection. With CISH, tissue and cell morphology can be evaluated simultaneously with the gene status by using bright-field microscopy and standard immunohistochemistry techniques (conventional peroxidase or alkaline phosphatase reactions). Genemed multiplex FISH allows for simultaneous detection of multiple targets using dual-colored probes. Chromosome 3 Centromere Digoxigenin Labeled CISH Probe CISH 70-0006 400 µl Chromosome 7 Centromere Digoxigenin Labeled CISH Probe CISH 70-0005 400 µl Chromosome 17 Centromere Digoxigenin Labeled CISH Probe CISH 70-0018 400 µl Chromosome X Centromere CISH Probe CISH 70-0016 400 µl Chromosome Y Region Yq12 CISH Probe CISH 70-0015 400 µl www.genemed.com 3

ISH - Probes EBER Digoxigenin Labeled CISH Probe CISH 70-0022 400 µl HER2 Digoxigenin Labeled CISH Probe CISH 70-0011 400 µl ABL Break Apart FISH Probe FISH 70-0026 100 µl Chromosome 3 Centromere Green FISH Probe FISH 70-0007 100 µl Chromosome 7 Centromere Green FISH Probe FISH 70-0010 100 µl Chromosome 17 Centromere Green FISH Probe FISH 70-0019 100 µl 4 IVD: In Vitro Diagnostic RUO: Research Use Only RTU: Ready-To-Use Concentrate Dilution: 1:100 unless indicated Application: Formalin-Fixed, Paraffin-Embedded

ISH - Probes Chromosome X Centromere Green FISH Probe FISH 70-0014 100 µl Chromosome Y Region Yq12 Red FISH Probe FISH 70-0013 100 µl Chromosome Y Region Yq12 Red and Chromosome X Centromere Green FISH Probe Cocktail FISH 70-0017 100 µl EGFR Green and Chromosome 7 Centromere Red FISH Probe Cocktail FISH 70-0024 100 µl HER2 Green and Chromosome 17 Centromere Red FISH Probe Cocktail FISH 70-0023 100 µl HER2 Red and Chromosome 17 Centromere Green FISH Probe Cocktail FISH 70-0012 100 µl www.genemed.com 5

ISH - Probes MALT Break Apart Fish Probe FISH 70-0027 100 µl TERC Red FISH Probe FISH 70-0008 100 µl TERC Red and Chromosome 3 Centromere Green Probe FISH Cocktail FISH 70-0009 100 µl TOPOIIa Green and Chromosome 7 Red Fish Probe Cocktail FISH 70-0025 100 µl 6 IVD: In Vitro Diagnostic RUO: Research Use Only RTU: Ready-To-Use Concentrate Dilution: 1:100 unless indicated Application: Formalin-Fixed, Paraffin-Embedded

ISH - Detection Kits & Ancillary Reagents In Situ Hybridization Detection Kit Genemed offers highly-sensitive polymer HRP detection systems for CISH applications. Genemed s sensitive and easy-to-use detection systems enable strong staining signals with lowest possible background. CISH HRP Detection Kit for DIG Labeled Probes Kit Includes HRP Conjugate for + AP for Intended Use 52-0025 20 tests (200µL per test) RUO Description This kit is a non-biotin system and utilizes a HRP (horseradish peroxidase) and AP (alkaline phoshatase) conjugates to locate where the mouse or rabbit primary antibody is bound to the target antigens. The complexes formed between HRP conjugate with mouse primary antibody and AP conjugate with rabbit primary antibody are observed through the use of two substrate-chromogen solutions, which when added sequentially, result in two colored precipitates at the antigen locations. The staining location and pattern is easily observable by light microscopy. In Situ Hybridization Ancillary Reagents Description Intended Use SSC Buffer (20X) 10-0029 100 ml RUO CISH Tissue Pretreatment Kit 10-0173 10mL/1000mL RUO www.genemed.com 7

Immunohistochemistry Primary Antibodies Genemed offers primary antibodies with high affinity and specificity for in vitro diagnostic and research use. Our primary antibodies are optimized and titrated for immunohistochemistry (IHC) testing using human formalin-fixed, paraffin-embedded (FFPE) tissue sections along with Genemed IHC Detection Systems and Ancillary reagents. Actin (Muscle) HHF35 61-0002, 61-0002-5, 61-0002-2 / 60-0002-7 Cytoplasm Positive Control Tissue Gastric Intestinal Tract Actin (Smooth Muscle) 1A4 61-0001, 61-0001-5, 61-0001-2 / 60-0001-7 IgG2a Cytoplasm Positive Control Tissue Gastrointestinal Tract AFP 61-0088-2 / 60-0088-7 Concentrate 0.2 ml / RTU 7 ml Cytoplasm Positive Control Tissue Hepatocellular Carcinoma AMACR 13H4 61-0096, 61-0096-5, 61-0096-2 / 60-0096-7 Cytoplasm Positive Control Tissue Prostate Cancer Bcl-2 Bcl-2-100 61-0005, 61-0005-5, 61-0005-2 / 60-0005-7 Cytoplasm 8 IVD: In Vitro Diagnostic RUO: Research Use Only RTU: Ready-To-Use Concentrate Dilution: 1:100 unless indicated Application: Formalin-Fixed, Paraffin-Embedded

CA19-9 (Sialyl Lewis) SPan-1 IgM 61-0142, 61-0142-5, 61-0142-2 / 60-0142-7 Positive Control Tissue Membrane and Cytoplasm Pancreas Calponin CALP 61-0105-2 / 60-0105-7 Concentrate 0.2 ml / RTU 7 ml Cytoplasm Positive Control Tissue Appendix, breast, leiomyoma, uterus Calretinin 61-0006, 61-0006-5, 61-0006-2 / 60-0006-7 Cytoplasm and Nucleus Positive Control Tissue Mesothelioma CD3 61-0011, 61-0011-5, 61-0011-2 / 60-0011-7 Membrane and Cytoplasm CD5 GR020 61-0183, 61-0183-5, 61-0183-2 / 60-0183-7 Membrane and Cytoplasm CD8 C8/144B 61-0124-2 / 60-0124-7 Concentrate 0.2 ml / RTU 7 ml Membrane, Spleen, Thymus www.genemed.com 9

CD10 GM003 61-0008, 61-0008-5, 61-0008-2 / 60-0008-7 IgG2b Membrane Positive Control Tissue Follicular lymphoma, diffuse large B-cell lymphoma CD19 GR014 Rabbi 61-0164, 61-0164-5, 61-0164-2 / 60-0164-7 Membrane CD20 B Cell L26 61-0010, 61-0010-5, 61-0010-2 / 60-0010-7 IgG2a Membrane CD23 GR013 61-0162, 61-0162-5, 61-0162-2 / 60-0162-7 Positive Control Tissue Membrane Tonsil CD30 Ber-H2 61-0007, 61-0007-5, 61-0007-2 / 60-0007-7 Membrane and Cytoplasm Positive Control Tissue Hodgkin Disease CD30 61-0188, 61-0188-5, 61-0188-2 / 60-0188-7 Membrane and Cytoplasm Positive Control Tissue ALCL or Hodgkin s Lymphoma 10 IVD: In Vitro Diagnostic RUO: Research Use Only RTU: Ready-To-Use Concentrate Dilution: 1:100 unless indicated Application: Formalin-Fixed, Paraffin-Embedded

CD31 (PECAM-1) GM006 61-0072, 61-0072-5, 61-0072-2 / 60-0072-7 Membrane CD34 QBend10 61-0012, 61-0012-5, 61-0012-2 / 60-0012-7 Membrane Positive Control Tissue GIST CD45 (LCA) GR009 61-0138, 61-0138-5, 61-0138-2 / 60-0138-7 Membrane Positive Control Tissue Tonsil CD45RO UCHL-1 IgG2a 61-0013, 61-0013-5, 61-0013-2 / 60-0013-7 Membrane CD56 (SCLC) 123C3 61-0062, 61-0062-5, 61-0062-2 / 60-0062-7 Cytoplasm and Membrane Positive Control Tissue Small cell lung carcinoma CD68 GR021 61-0184, 61-0184-5, 61-0184-2 / 60-0184-7 Cytoplasm www.genemed.com 11

CD79a GR019 61-0182, 61-0182-5, 61-0182-2 / 60-0182-7 Membrane and Cytoplasm CDX2 GR023 61-0186, 61-0186-5, 61-0186-2 / 60-0186-7 Nucleus Positive Control Tissue Colon Cancer CEA COL-1 61-0014, 61-0014-5, 61-0014-2 / 60-0014-7 IgG2a Cytoplasm and Membrane Positive Control Tissue Colon Cancer Chromogranin A 61-0015, 61-0015-5, 61-0015-2 / 60-0015-7 Cytoplasm granular Positive Control Tissue Neuroendocrine Tumor c-kit (CD117) 61-0020, 61-0020-5, 61-0020-2 / 60-0020-7 Membrane and Cytoplasm Positive Control Tissue Gastrointestinal Stromal Tumor Cyclin D1 AM29 IgG2a 61-0021, 61-0021-5, 61-0021-2 / 60-0021-7 Nucleus Positive Control Tissue Mantle Cell Lymphoma or Breast Cancer 12 IVD: In Vitro Diagnostic RUO: Research Use Only RTU: Ready-To-Use Concentrate Dilution: 1:100 unless indicated Application: Formalin-Fixed, Paraffin-Embedded

Cyclin D1 GR005 61-0090, 61-0090-5, 61-0090-2 / 60-0090-7 Nucleus Positive Control Tissue Mantle Cell Lymphoma or Breast Cancer Cytokeratin AE1/AE3 61-0022, 61-0022-5, 61-0022-2 / 60-0022-7 Cytoplasm Positive Control Tissue Tissue with epithelial cells Cytokeratin AE1 61-0023, 61-0023-5, 61-0023-2 / 60-0023-7 Cytoplasm Positive Control Tissue Tissue with epithelial cells Cytokeratin C11 61-0053, 61-0053-5, 61-0053-2 / 60-0053-7 Positive Control Tissue Cytokeratin 5 GM028 61-0174, 61-0174-5, 61-0174-2 / 60-0174-7 Cytoplasm Positive Control Tissue Mesothelioma, prostate Cytokeratin 5/6 D5/16B4 61-0016-2 / 60-0016-7 Concentrate 0.2 ml / RTU 7 ml Cytoplasm Positive Control Tissue Mesothelioma, prostate www.genemed.com 13

Cytokeratin 7 OV-TL 12/30 61-0019, 61-0019-5, 61-0019-2 / 60-0019-7 Positive Control Tissue Cytoplasm Lung Adenocarcinoma Cytokeratin 18 DC-10 61-0017, 61-0017-5, 61-0017-2 / 60-0017-7 Cytoplasm Positive Control Tissue Gastric intestinal tract Cytokeratin 19 A53-B/A2.26 61-0163-2 / 60-0163-7 IgG2a Concentrate 0.2 ml / RTU 7 ml Cytoplasm Positive Control Tissue Tonsil, Salivary Gland, and GI Tract Cytokeratin 20 Ks20.8 61-0018, 61-0018-5, 61-0018-2 / 60-0018-7 IgG2a Cytoplasm Positive Control Tissue Colon Cancer Cytokeratin HMW 34bE12 61-0025, 61-0025-5, 61-0025-2 / 60-0025-7 Cytoplasm and Membrane Positive Control Tissue Prostate D2-40 D2-40 61-0100-2 / 60-0100-7 Concentrate 0.2 ml / RTU 7 ml Cytoplasm and some membrane Positive Control Tissue Lymph Node 14 IVD: In Vitro Diagnostic RUO: Research Use Only RTU: Ready-To-Use Concentrate Dilution: 1:100 unless indicated Application: Formalin-Fixed, Paraffin-Embedded

Desmin GM007 61-0077, 61-0077-5, 61-0077-2 / 60-0077-7 Positive Control Tissue Cytoplasm Uterus E-Cadherin GM016 61-0028, 61-0028-5, 61-0028-2 / 60-0028-7 Membrane and some cytoplasm Positive Control Tissue Esophagus, Endometrium EGFR GR018 61-0181, 61-0181-5, 61-0181-2 / 60-0181-7 Positive Control Tissue EMA GM008 61-0030-2 / 60-0030-7 IgG2a Concentrate 0.2 ml / RTU 7 ml Cytoplasm and Membrane Positive Control Tissue Breast Carcinoma Ep-Cam VU-1D9 61-0190, 61-0190-5, 61-0190-2 / 60-0190-7 Membrane and Cytoplasm Positive Control Tissue Colon, Thyroid ER 1D5 61-0031, 61-0031-5, 61-0031-2 / 60-0031-7 Intended Use USA ASR, CE IVD Positive Control Tissue www.genemed.com 15

ER GR001 61-0068, 61-0068-5, 61-0068-2 / 60-0068-7 Positive Control Tissue ER EP1 61-0157, 61-0157-5, 61-0157-2 / 60-0157-7 Positive Control Tissue ER GM029 61-0176, 61-0176-5, 61-0176-2 / 60-0176-7 Nucleus Positive Control Tissue Breast Carcinoma Galectin-3 9C4 IgG2aMo et hitatem licimoditi doluptam enis ut 61-0133-2 / 60-0133-7 Concentrate 0.2 ml / RTU 7 ml Cytoplasm Positive Control Tissue Papillary or Follicular Carcinoma of Thyroid GFAP 61-0032, 61-0032-5, 61-0032-2 / 60-0032-7 Cytoplasm Positive Control Tissue Astrocytomas HER2 GR011 61-0154, 61-0154-5, 61-0154-2 / 60-0154-7 Breast Cancer Intended Use USA ASR, CE IVD Positive Control Tissue 16 IVD: In Vitro Diagnostic RUO: Research Use Only RTU: Ready-To-Use Concentrate Dilution: 1:100 unless indicated Application: Formalin-Fixed, Paraffin-Embedded

Human Chorionic Gonadotropin (hcg) 61-0125, 61-0125-5, 61-0125-2 / 60-0125-7 Positive Control Tissue Cytoplasm and Membrane Tonsil Human Kappa Light Chain HP6053 61-0037, 61-0037-5, 61-0037-2 / 60-0037-7 Cytoplasm and Membrane Human Kappa Light Chain 61-0085, 61-0085-5, 61-0085-2 / 60-0085-7 Cytoplasm and Membrane Human Lambda Light Chain HP6054 61-0038, 61-0038-5, 61-0038-2 / 60-0038-7 IgG2a Cytoplasm and Membrane Human Lambda Light Chain 61-0086, 61-0086-5, 61-0086-2 / 60-0086-7 Cytoplasm and Membrane Insulin 2D11-H5 61-0039, 61-0039-5, 61-0039-2 / 60-0039-7 Cytoplasm Positive Control Tissue Pancreas www.genemed.com 17

Ki-67 GM010 IgG2b 61-0078, 61-0078-5, 61-0078-2 / 60-0078-7 Nucleus Positive Control Tissue Tonsil Laminin 60-0113-7 RTU 7 ml USA IVD, CE IVDEctatum Lysozyme (Muramidase) 61-0118, 61-0118-5, 61-0118-2 / 60-0118-7 Cytoplasm or Lymph Node Melan-A A103 61-0092-2 / 60-0092-7 Concentrate 0.2 ml / RTU 7 ml Cytoplasm Positive Control Tissue Melanoma Melanosome HMB45 61-0042, 61-0042-5, 61-0042-2 / 60-0042-7 Cytoplasm Positive Control Tissue Melanoma Mesothelial Cell HBME-1 61-0127-2 / 60-0127-7 IgM Concentrate 0.2 ml / RTU 7 ml Membrane and cytoplasm Positive Control Tissue Mesothelioma or Salivary Gland or Spleen 18 IVD: In Vitro Diagnostic RUO: Research Use Only RTU: Ready-To-Use Concentrate Dilution: 1:100 unless indicated Application: Formalin-Fixed, Paraffin-Embedded

MLH1 GM011 61-0079, 61-0079-5, 61-0079-2 / 60-0079-7 Nucleus Positive Control Tissue Colon MSH6 GM024 61-0158, 61-0158-5, 61-0158-2 / 60-0158-7 IgG2a Nucleus Positive Control Tissue Colon Cancer MUC5AC Nd-2 61-0160, 61-0160-5, 61-0160-2 / 60-0160-7 Cytoplasm and Perinuclear Positive Control Tissue Stomach MyoD1 5.8A 61-0101-2 / 60-0101-7 Concentrate 0.2 ml / RTU 7 ml Nucleus Positive Control Tissue Rhabdomyosarcoma Myogenin F5D 61-0149-2 / 60-0149-7 Concentrate 0.2 ml / RTU 7 ml Nucleus Positive Control Tissue Rhabdomyosarcoma N-Cadherin GM031 61-0187, 61-0187-5, 61-0187-2 / 60-0187-7 Membrane and Cytoplasm Positive Control Tissue Gastrointestinal Tract www.genemed.com 19

Neurofilaments (Pan) 2F11 61-0048, 61-0048-5, 61-0048-2 / 60-0048-7 Concentrate (1:60) 1 ml, 0.5 ml, 0.2 ml / RTU 7 ml Positive Control Tissue Cytoplasm Paraganglioma Non-Immune Immunoglobulin 60-0045-7 RTU 7 ml No staining Positive Control Tissue Non-Immune Immunoglobulin 60-0060-7 RTU 7 ml No staining Positive Control Tissue p53 BP-53-12 61-0050, 61-0050-5, 61-0050-2 / 60-0050-7 IgG2a Concentrate 1 ml, 0.5 ml, 0.2 ml / RTU 7 ml Positive Control Tissue Nucleus Selective Squamous Cell Carcinoma p63 4B1E12 IgG2b 60-0074-7 RTU 7 ml Nucleus Positive Control Tissue Prostate For outside USA only PAX5 (B Cell Specific Activation Protein) GR024 61-0093, 61-0093-5, 61-0093-2 / 60-0093-7 Nucleus 20 IVD: In Vitro Diagnostic RUO: Research Use Only RTU: Ready-To-Use Concentrate Dilution: 1:100 unless indicated Application: Formalin-Fixed, Paraffin-Embedded

PCNA PC10 IgG2a 61-0054, 61-0054-5, 61-0054-2 / 60-0054-7 Nucleus Positive Control Tissue Tonsil PLAP GM022 61-0139, 61-0139-5, 61-0139-2 / 60-0139-7 IgG2b Cytoplasm and membrane Positive Control Tissue Placenta, Seminoma PR Y85 61-0056, 61-0056-5, 61-0056-2 / 60-0056-7 Intended Use USA ASR, CE IVD Positive Control Tissue PSA 61-0058, 61-0058-5, 61-0058-2 / 60-0058-7 Intended Use USA IVD, EU RUO Cytoplasm Positive Control Tissue Prostate PsAP PASE/4LJ 61-0104, 61-0104-5, 61-0104-2 / 60-0104-7 Cytoplasm Positive Control Tissue Prostate S-100 61-0061, 61-0061-5, 61-0061-2 / 60-0061-7 Cytoplasm Positive Control Tissue Melanoma www.genemed.com 21

Synaptophysin GR007 61-0122, 61-0122-5, 61-0122-2 / 60-0122-7 Positive Control Tissue Cytoplasm Neuroendocrine Tumor TdT 61-0115-2 / 60-0115-7 Concentrate 0.2 ml / RTU 7 ml IgG2aMo et hitatem licimoditi doluptam enis ut Nucleus Positive Control Tissue Thymus Thyroglobulin 2H11/6E1 61-0064, 61-0064-5, 61-0064-2 / 60-0064-7 Cytoplasm and extracellular Positive Control Tissue Thyroid TTF-1 8G7G3/1 61-0065, 61-0065-5, 61-0065-2 / 60-0065-7 Nucleus Positive Control Tissue Thyroid Villin GR016 61-0170-2 / 60-0170-7 Concentrate 0.2 ml / RTU 7 ml Membrane and/or Cytoplasm Positive Control Tissue Small Intestine or Colonic Mucosa Vimentin V9 61-0066, 61-0066-5, 61-0066-2 / 60-0066-7 Cytoplasm Positive Control Tissue Any Tissue 22 IVD: In Vitro Diagnostic RUO: Research Use Only RTU: Ready-To-Use Concentrate Dilution: 1:100 unless indicated Application: Formalin-Fixed, Paraffin-Embedded

Von Willebrand Factor (Factor VIII RA) 61-0109, 61-0109-5, 61-0109-2 / 60-0109-7 Cytoplasm WT1 6F-H2 61-0135-2 / 60-0135-7 Concentrate 0.2 ml / RTU 7 ml Nucleus and cytoplasm Positive Control Tissue Wilms Tumor www.genemed.com 23

IHC - Detection Kit Immunohistochemistry Detection Kits Genemed offers highly-sensitive polymer detection systems for immunohistochemistry applications. Genemed s sensitive and easy-touse detection systems enable strong staining signals with lowest possible background. We provide ready-to-use IHC detection reagents to meet variable needs, e.g. for mouse, or/and rabbit primary antibody; peroxidase (HRP) or alkaline phosphatase (AP) enzymes. Power-Stain 1.0 Kit HRP DAB for + Kit Includes HRP Conjugate for +, DAB Chromogen and Buffer Solutions 52-0017, 54-0017 15 ml, 100 ml No. of Tests 150/1000 Description This kit is a non-biotin system and utilizes a HRP (horseradish peroxidase) conjugate to locate where the mouse or rabbit primary antibody is bound to the target antigen. The complex formed between HRP conjugate and the mouse or rabbit primary antibody is observed through the use of a substrate-chromogen solution, which when added, results in a colored precipitate at the antigen location. The staining location and pattern is easily observable by light microscopy. Power-Stain 1.0 Kit HRP AEC for + Kit Includes HRP Conjugate for +, AEC Substrate (Single Solution) 52-0022, 54-0022 Description This kit is a non-biotin system and utilizes a HRP (horseradish peroxidase) conjugate to locate where the mouse or rabbit primary antibody is bound to the target antigen. The complex formed between HRP conjugate and the mouse or rabbit primary antibody is observed through the use of a substrate-chromogen solution, which when added, results in a colored precipitate at the antigen location. The staining location and pattern is easily observable by light microscopy. Power-Stain 2.0 HRP Kit for + Kit Includes HRP Conjugate for +, Linker for + Antibody Intended Use 52-0006, 54-0006 15 ml, 100 ml USA IVD, CE IVD No. of Tests 150/1000 Description This kit is a non-biotin system and utilizes linker to locate where the mouse and/or rabbit primary antibody is bound to the target antigen. HRP (horseradish peroxidase) conjugate is then applied and binds to the linker. This complex is observed through the use of a substrate-chromogen solution, which when added, results in a colored precipitate at the antigen location. The staining location and pattern is easily observable by light microscopy. 24 IVD: In Vitro Diagnostic RUO: Research Use Only RTU: Ready-To-Use Concentrate Dilution: 1:100 unless indicated Application: Formalin-Fixed, Paraffin-Embedded

IHC - Detection Kit Acu-Stain HRP Kit + Kit Includes Blocking Solution, Biotinylated Goat anti- + Secondary Antibody, Streptavidin-Peroxidase (HRP) 52-0003, 54-0003 15 ml, 100 ml No. of Tests 150/1000 Description This kit utilizes a biotinlyated secondary antibody to locate where the mouse and/or rabbit primary antibody is bound to the target antigen. Streptavidin-HRP (horseradish peroxidase) is then applied and binds to the secondary antibody. This complex is observed through the use of a substratechromogen solution, which when added, results in a colored precipitate at the antigen location. The staining location and pattern is easily observable by light microscopy. Power-Stain 1.0 Double Stain Kit I ( HRP for + AP for ) Kit Includes HRP Conjugate for + AP for Intended Use 52-0023 15 ml USA IVD, CE IVD No. of Tests 150 Description This kit is a non-biotin system and utilizes a HRP (horseradish peroxidase) and AP (alkaline phosphatase) conjugates to locate where the mouse or rabbit primary antibody is bound to the target antigens. The complexes formed between HRP conjugate with mouse primary antibody and AP conjugate with rabbit primary antibody are observed through the use of two substrate-chromogen solutions, which when added sequentially, result in two colored precipitates at the antigen locations. The staining location and pattern is easily observable by light microscopy. Power-Stain 1.0 Kit AP for + Kit Includes AP Conjugate for +, AP Substrate-Chromogen Solution 52-0020 15 ml No. of Tests 150/1000 Description This kit is a non-biotin system and utilizes a AP (alkaline phosphatase) conjugate to locate where the mouse or rabbit primary antibody is bound to the target antigen. The complex formed between AP conjugate and the mouse or rabbit primary antibody is observed through the use of a substrate-chromogen solution, which when added, results in a colored precipitate at the antigen location. The staining location and pattern is easily observable by light microscopy. www.genemed.com 25

IHC - Ancillary Reagents Immunohistochemistry Ancillary Reagents Description Intended Use Buffer PBS Powder (1L of 10X per pouch) 10-0044 2 Pouches USA IVD, CE IVD TBST (Tris Buffered Saline and 0.05% Tween 20), ph 7.4 (20X) 10-0028 100 ml USA IVD, CE IVD Chromogen AEC Substrate (Single Solution) 10-0047, 10-0005 15 ml, 100 ml USA IVD, CE IVD BCIP/NBT Substrate Kit 10-0007 100 ml RUO Sensitive DAB Substrate Kit 10-0048 200 ml USA IVD, CE IVD Conjugate AP Streptavidin Conjugate 10-0011 1 ml RUO Biotin Goat anti- IgG+ IgM (H+L) 10-0012 1 ml RUO Biotin Goat anti- IgG (H+L) 10-0013 1 ml RUO HRP Streptavidin Conjugate 10-0010 1 ml RUO Diluent Antibody Diluent for Automated Stainers 10-0058 500 ml USA IVD, CE IVD Primary Antibody Diluent 10-0001 500 ml USA IVD, CE IVD Counterstain & Mounting CleanMount Aqueous Mounting Solution 10-0034 15 ml USA IVD, CE IVD GVA Aqueous Mounting Solution 10-0033 15 ml USA IVD, CE IVD Mayer's Hematoxylin 10-0027 100 ml USA IVD, CE IVD Mini PAP Pen 10-0041 Ea USA IVD, CE IVD Super PAP Pen 10-0045 Ea USA IVD, CE IVD Prestaining A/B Block (Avidin/Biotin Blocking Solution) 10-0039 15 ml USA IVD, CE IVD C-Block (Casein Blocking Solution) 10-0040 100 ml USA IVD, CE IVD Blocking Solution 10-0032 100 ml USA IVD, CE IVD Pretreatment Citrate Buffer, ph 6 (1X) 10-0022 1000 ml USA IVD, CE IVD Citrate Buffer, ph 6 (20X) 10-0020 100 ml USA IVD, CE IVD Peroxidase Blocking Solution 10-0056 100 ml USA IVD, CE IVD Proteinase K 10-0024 50 ml USA IVD, CE IVD Tris EDTA Buffer, ph 9 (1X) 10-0046 1000 ml USA IVD, CE IVD Tris EDTA Buffer, ph 9 (20X) 10-0037 100 ml USA IVD, CE IVD 26

Index Product List by Name A/B Block (Avidin/Biotin Blocking Solution) 26 ABL Break Apart Fish Probe 4 Actin (Muscle) 8 Actin (Smooth Muscle) 8 Acu-Stain HRP + AEC Substrate (Single Solution) 25 26 AFP 8 AMACR 8 Antibody Diluent for Automated Stainers 26 AP Streptavidin Conjugate 26 BCIP/NBT Substrate Kit 26 Bcl-2 8 Biotin Goat anti- IgG+M (H+L) Biotin Goat anti- IgG (H+L) Blocking Solution (Nonimmune) C-Block (Casein Blocking Solution) 26 26 26 26 CA19-9 (Sialyl Lewis) 9 Calponin 9 Calretinin 9 CD3 9 CD5 9 CD8 9 CD10 10 CD19 10 CD20 B Cell 10 CD23 10 CD30 10 CD31 (PECAM-1) 11 CD34 11 CD45 (LCA) 11 CD45RO 11 CD56 (SCLC) 11 CD68 11 CD79α 12 CDX2 12 Chromosome 7 Centromere Digoxigenin Labeled CISH Probe Chromosome 7 Centromere Green FISH Probe Chromosome 17 Centromere Digoxigenin Labeled CISH Probe Chromosome 17 Centromere Green FISH Probe Chromosome X Centromere CISH Probe Chromosome X Centromere Green FISH Probe Chromosome Y Region Yq12 CISH Probe Chromosome Y Region Yq12 Red FISH Probe Chromosome Y Yq12 Red & Chromosome X Centromere Green FISH Probe Cocktail CISH HRP Detection Kit for DIG Labeled Probes Citrate Buffer ph 6 (1X) 26 Citrate Buffer ph 6 (20X) 26 c-kit (CD117) 12 CleanMount Aqueous Mounting Solution 3 4 3 4 3 5 3 5 5 7 26 Cyclin D1 12 Cyclin D1 13 Cytokeratin 13 Cytokeratin 5 13 Cytokeratin 5/6 13 Cytokeratin 7 14 Cytokeratin 18 14 Cytokeratin 19 14 Cytokeratin 20 14 Cytokeratin HMW 14 D2-40 14 Desmin 15 E-cadherin 15 EBER Digoxigenin Labeled CISH Probe EGFR 15 EGFR Green and Chromosome 7 Centromere Red FISH Probe Cocktail 4 5 Galectin-3 16 GFAP 16 GVA Aqueos Mounting Solution 26 HER2 16 HER2 CISH Kit 2 HER2 Digoxigenin Labeled CISH Probe HER2 Green and Chromosome 17 Centromere Red FISH Probe Cocktail HER2 Red and Chromosome 17 Centromere Green FISH Probe Cocktail HRP Streptavidin Conjugate 26 Human Chorionic Gonadotropin (hcg) 4 5 5 17 Human Kappa Light Chain 17 Human Lambda Light Chain 17 Insulin 17 ISH Tissue Pretreatment Kit 7 Ki-67 18 Laminin 18 Lysozyme (Muramidase) 18 MALT Break Apart FISH Probe Mayer's Hematoxylin 26 Melan-A 18 Melanosome 18 Mesothelial Cell 18 Mini PAP Pen 26 MLH1 19 MSH6 19 MUC5AC 19 MyoD1 19 Myogenin 19 N-Cadherin 19 Neurofilaments (Pan) 20 Non-Immune Immunoglobulin Non-Immune Immunoglobulin 6 20 20 p53 20 Peroxidase Blocking Solution 26 PLAP 21 Power-Stain 1.0 Double Stain Kit I ( HRP for + AP for ) Power-Stain 1.0 Kit AP for + Power-Stain 1.0 Kit HRP AEC for + Power-Stain 1.0 Kit HRP DAB for + Power-Stain 2.0 Kit HRP for + 25 25 24 24 24 PR 21 Primary Antibody Diluent 26 Proteinase K 26 PSA 21 PsAP 21 S-100 21 Sensitive DAB Substrate Kit 26 SSC Buffer (20X) 7 Super PAP Pen 26 Synaptophysin 22 TBST (Tris Buffered Saline and 0.05% Tween 20), ph 7.4 (20X) 26 TdT 22 TERC Red FISH Probe 6 TERC Red and Chromosome 3 Centromere Green Probe FISH Cocktail Thyroglobulin 22 TOPOIIa Green and Chromosome 7 Red Fish Probe Tris EDTA Buffer ph 9 (1X) 26 Tris EDTA Buffer ph 9 (20X) 26 TTF1 22 Villin 22 Vimentin 22 Von Willebrand Factor (Factor VIII RA) 6 6 23 WT1 23 CEA 12 EMA 15 p63 20 Chromogranin A 12 Chromosome 3 Centromere Digoxigenin Labeled CISH Probe Chromosome 3 Centromere Green FISH Probe 3 4 Ep-Cam 15 ER 15 ER 16 ER 16 ER 16 PAX5 (B cell Specific Activation Protein) 20 PBS Powder (10X) 26 PCNA 21 28

A wholly-owned subsidiary of Sakura Finetek U.S.A., Inc. 2017 Genemed All Rights Reserved Deksan Laboratuar Sistemleri Ltd Sti Altaycesme Mahallesi, Cam Sokak no: 16/80 34843 Istanbul Turkey Tel:+90 216 417 94 14 info@deksan.net www.deksan.net PN31371 Rev.03 www.genemed.com