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False negative results found in prognostic testing for breast cancer
Date:6/18/2014

itive on repeat testing. Many of these cases were detected as being positive by testing for HER2 using both of two different and complementary tests (IHC and FISH, as described below).

The repercussions of incorrectly identifying a cancer's subtype are considerable. "While it is comforting that only four percent of these women were misclassified initially, this is an enormous issue for those who fall into this group," said Kaufman. "This is because HER2 targeted therapies are critically important for women with HER2 positive breast cancer."

The variance in accuracy may be related to how tests are conducted in smaller versus larger pathology laboratories. Two different tests are approved for and widely used for HER2: immunohistochemistry (IHC) or florescence in situ hybridization (FISH). Either test may be used to determine a woman's HER2 status. Frequently, based on recommendations by leading oncology groups, one or the other is used. In this case, using both tests allowed researchers to uncover errors resulting from reliance on a single test. Of the 22 samples incorrectly categorized, 18 had been processed by a local laboratory using only one testing method.

The analysis was based on the VIRGO study, a large, disease-based, observational cohort study of more than 1,200 women with HER2-negative metastatic breast cancer from June 2008 through January 2011. Out of the 1,267 patients enrolled in VIRGO, 776 submitted samples for this study from which 552 were suitable for centralized testing using IHC and FISH assays.


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Contact: Donna Dubuc
donna.M.Dubuc@Dartmouth.edu
603-653-3615
The Geisel School of Medicine at Dartmouth
Source:Eurekalert

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