PATHOLOGY. HercepTestTM. Product Information

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1 PATHOLOGY HercepTestTM Product Information

2 CLINICAL TRIALS HercepTest The First and Foremost Dako s pharmdx HercepTest was the first FDA-approved assay developed exclusively to aid physicians in identifying breast cancer patients most likely to benefit from treatment with the anti-her2 monoclonal antibody trastuzumab (Herceptin, Genentech). For almost ten years, laboratories around the world have relied on HerceptTest, the first and most documented FDA- approved HER2 testing kit. HercepTest is a semi-quantitative immunohistochemical (IHC) assay that identifies overexpression of the human epidermal growth factor receptor 2 gene erbb2 (commonly referred to as HER2) in breast tissue. HER2 testing is recommended for all newly diagnosed breast cancers by the American Society of Clinical Oncology (ASCO), the College of American Pathology (CAP) and the National Comprehensive Cancer Network (NCCN). Worldwide, HercepTest is trusted and acknowledged as a reliable and robust assay for HER2 overexpression. In the NordiQC Assessment Run 2006, HercepTest was the most reliable for the semi-quantitative immunohistochemical determination of HER2 protein*. UK-NEQAS has recommended HercepTest for firstline screening of breast cancer patients. HercepTest showed excellent concordance with FISH in 0, 1+ and 3+ cases**. In the US, HercepTest was the first FDA-approved assay for identifying HER2 overexpression. Recent publications of large controlled clinical trials provide scientific support for the use of HercepTest to aid in the selection of breast cancer patients who might benefit for the use of Herceptin therapy 1. * 2006 NordiQC Assessment Run B1 HER2 ** UK-NEQUAS Breast HER2 Module 2003 HercepTest Highlights FDA-approved test indicated as an aid to assess breast cancer patients who may be eligible for Herceptin. A complete assay with demonstrated sensitivity and specificity. Convenient, easy-to-use optimized reagents and protocol. Control cell line slides included for validation of each staining run. Reproducible, robust and reliable. Backed by superior technical support and customer service. HercepTest Interpretation Manual includes scoring guidelines and reference staining atlas. Consistency is Key Roughly 20 percent of breast cancers are HER2 positive. Since trastuzumab therapy is cardiotoxic in some cases, accurate and consistent test results are essential for responsible patient care. Unfortunately, there can be wide variation in HER2 results. The average false-positive rate for IHC HER2 protein overexpression is 18 percent. Error rates are higher in small-volume laboratories not using automated stainers or FDA-approved kits. In fact, one study found a 25 percent false-positive rate for laboratories using an IHC method other than HercepTest 2. Using Dako s recommended protocols and reagents, HercepTest will provide accurate, reproducible results. HercepTest TM and Herceptin are registered trademarks of Genentech, Inc. subject to licenses held by Dako and F. Hoffman-La Roche Ltd. ACIS is a registered trademark of Clarient, Inc.

3 Assistance from ACIS Variability in staining from using non-fda-approved test kits is only one reason for inconsistent results. Interpretation is also a factor. To aid in the consistency of HER2 scoring, increasing numbers of laboratories and pathologists rely on Dako s ACIS, an automated cellular imaging system, to objectively quantify results. ACIS III is optimized for use with Dako s HercepTest TM. When used in conjunction with HercepTest TM, the system s image analysis application may assist pathologists in more consistently determining the status of HER2 protein expression, aiding in the assessment of breast cancer patients eligible for Herceptin therapy. IHC vs FISH HER2 protein overexpression is detected directly through IHC and indirectly through gene amplification using FISH. Despite numerous studies, there is no conclusive evidence that one test is more accurate than the other. However, in equivocal cases, it is recommended that the IHC test be reflexed to a FISH assay. Dako has received FDA approval for HercepTest (IHC) and HER2 FISH pharmdx (ISH). IHC and FISH Targets for HER2 Testing HER2 Receptors FISH DNA IHC mrna Transcript Breast Cancer Cell HER2 Testing Algorithm HER2 gene amplification is the underlying biological change that results in HER2 overexpression. Tumor Sample HER2 IHC 0 Negative 1+ Negative 2+ Weakly Positive (Equivocal)* 3+ Positive HER2 FISH Report to Oncologist for Herceptin Consideration Negative Non-Amplified Positive Amplified Current clinical practices for selection of patients for Herceptin treatment. NCCN Practice Guidelines in Oncology, CAP Conference Summary Laboratories performing HER2 testing should meet quality assurance standards. *Weakly positive cases (2+): May be considered equivocal and reflexed to FISH testing.

4 Interpretation To determine HER2 protein overexpression, membrane staining intensity and pattern should be evaluated by a pathologist using a light microscope. The scoring system included with HercepTest matches that of Genentech s IHC Clinical Trial Assay (CTA) for Herceptin. HER2 Protein Score to Overexpression Staining Report Assessment Pattern 0 Negative No staining is observed, or membrane staining is observed in <10% of the tumor cells. 1+ Negative A faint/barely perceptible membrane staining is detected in >10% of tumor cells. The cells exhibit incomplete membrane staining. 2+ Weakly Positive* A weak to moderate complete membrane staining is observed in (Equivocal) >10% of tumor cells. 3+ Strongly Positive** A strong complete membrane staining is observed in >10% of tumor cells. * May be considered equivocal and reflexed to FISH testing. ** Based on recent testing guidelines a 30% cut-off for reporting positivity is recommended 3. FDA approved scoring guidelines recommend a 10% cut-off for reporting positivity. Patient outcome for cases resulting between 10% and 30% positivity has not been defined. FISH may be used as a complementary test in these instances. Quality Control The control cell lines are provided to help qualify the procedure and reagents, not as an interpretation reference. 0 control cell line MDA-231 stained with HercepTest. No staining of the membrane is observed. 20x magnification. 1+ control cell line MDA-175 stained with HercepTest. A faint perceptible staining of the membrane is observed. The cells are only stained in part of their membrane. 20x magnification. 3+ control cell line SK-BR-3 stained with HercepTest. A strong staining of the entire membrane is observed. 20x magnification. To aid in the differentiation of 0, 1+, 2+ and 3+ staining refer to Dako s HercepTest Interpretation Manual for representative pictures of staining intensities. HER2

5 HercepTest Kit Components HercepTest is a complete kit and includes: Peroxidase-Blocking Reagent. Rabbit Anti-Human HER2 Protein. Visualization Reagent. Negative Control Reagent. DAB Buffered Substrate. Epitope Retrieval Solution (10x). Wash Buffer (10x) (not included in SK001). Control Slides. User-Filable Bottles (only included in SK001). Protocol and Interpretation Guidelines. DAB Chromogen. Product 35-Test HercepTest for manual use 50-Test HercepTest for the Dako Autostainer/Autostainer Plus 50-Test HercepTest for Automated Link Platforms Code K5204 K5207 SK001 The Dako Autostainer Link 48 (code AS480) provides automated staining. Supporting Literature For information about supporting literature, contact your local Dako representative or visit COMPONENTS Since September 1998, Dako has led the personalized medicine revolution with companion diagnostics for targeted therapies. Our goal is to continue to lead the way by providing clinically relevant tools needed to make the custom treatment algorithms a reality for pathologists, clinicians and patients. We are proud of our pharmacodiagnostic product portfolio that includes HercepTest, c-kit pharmdx, ER/PR pharmdx, HER2 FISH pharmdx and EGFR pharmdx.

6 References 1 Piccart-Gebhart, Proter M, Leyland-Jones B, Goldhirsch A, et al. Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. NEJM 2005;353: Perez EA, et al. J Clin Oncol 2006;24: Wolff AC, Hammond EH, Schwartz JN, Hagerty KL, Allred DG, Cote RJ, et al: American Society of Clinical Oncology/College of American Pathologists Guideline Recommendations for Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer. Arch Pathol Lab Med 2007 January;131: Corporate Headquarters Denmark Distributors in more than 60 countries Australia Austria Belgium +32 (0) Brazil Canada China Denmark Finland France Germany Ireland Italy Japan The Netherlands Norway Poland Spain Sweden Switzerland United Kingdom +44 (0) United States of America MAY10

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