PhenoPath Laboratories is pleased to announce our
HER2 Validation Studies
The newly published ASCO-CAP HER2 Testing Guidelines mandate that laboratories performing their own IHC studies for HER2 status of breast cancer perform concordance studies with HER2 gene status on 25-100 breast cancer cases, as a validation of the accuracy of HER2 IHC testing.
PhenoPath Laboratories will help you meet these new requirements by performing HER2 FISH studies on cases tested via IHC in your laboratory as part of this QA/QC program. Unique among reference laboratories, 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. Unlike many other laboratories, 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.
The ASCO-CAP 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).
Please contact PhenoPath Laboratories for additional information concerning HER2 validation studies.
PhenoPath pathologists and staff will be happy to work with you to improve the overall quality of HER2 testing in breast cancer, fulfilling the mission of the ASCO-CAP Guidelines.
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- Questions and answers about HER2 validation and PhenoPath's validation service.