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HER2 ValidationRecently published guidelines from the American Society of Clinical Oncologists (ASCO) and the College of American Pathologists (CAP) mandate that concordance studies be performed by all laboratories performing HER2 IHC testing of breast cancer specimens. The guidelines presently require a 95% concordance of HER2 IHC and FISH for positive and negative cases (i.e., 3+ by IHC for gene amplification by FISH and 0 or 1+ by IHC for absence of gene amplification by FISH). PhenoPath Laboratories will help you meet these new requirements by performing HER2 FISH studies on cases tested via IHC in your laboratory. PhenoPath has published its IHC FISH concordance data incorporating results on more than 6,000 cases, most recently in presentations at the San Antonio Breast Cancer Symposium (2006) and the United States Canadian Academy of Pathology (2007). The extremely high concordance levels attained at PhenoPath reflect our many years of experience in HER2 testing and our robust HER2 QA program. At PhenoPath Laboratories FISH interpretation is performed by pathologists, not technologists. Furthermore, FISH quantification is performed using a Metasystems™ morphometric image analysis system. FISH results on the 25-100 cases will be reported out in a spreadsheet.
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