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Seattle-based PhenoPath Laboratories Retests Nearly 3,000 Breast Cancer Specimens from Quebec Breast Cancer Inquiry
Date:12/20/2009

. Allen M. Gown, an internationally recognized expert in the technique of IHC, and the laboratory has become a highly respected national reference laboratory for the performance of IHC and other specialized pathology testing of breast and other tumors. The laboratory was involved in a landmark study published in December 2006 demonstrating that reagents employed for the identification of ER in breast cancer specimens at PhenoPath Laboratories were significantly more sensitive and specific than those widely used in the United States and around the world. PhenoPath’s vast experience and expertise with IHC in this context was a major factor in the selection of this laboratory by the Province of Quebec for this retesting.

In the re-analysis, results of which were just announced, a total of 87 women were found to have received a false negative result from the original pathology laboratory tests in Quebec. Of this number, 39 were required to alter their treatment and among them five women died. Minister of Health Yves Bolduc said it was impossible to determine whether the women died as a result of being improperly treated.

Despite the relatively low rate of “false negative” ER tests revealed by the PhenoPath Laboratories retesting of the original Quebec laboratory results, given the absence of standardization and comparable retesting studies in the United States, and the additional potential sources of error not addressed in this retesting, the error rate in ER testing in breast cancer in laboratories the United States remains uncertain.

About PhenoPath Laboratories:
PhenoPath Laboratories is a national anatomic pathology reference laboratory located in Seattle, Washington. PhenoPath provides consultation services and diagnostic and research applications of immunohistochemistry (IHC), flow cytometry, FISH, CISH and PCR testing to pathologists and clinical laboratories across the United States and the world.


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