Category Archives: blog

Equivocal is Not a Genomic Subtype

Per NCCN guidelines, all newly diagnosed, recurrent, and metastatic breast cancers are evaluated for HER2 positivity. Tumors highly amplified for HER2 receptor protein expression are predicted to respond to anti-HER2 therapies. Thus, accurate reporting of the HER2 genomic subtype of each and every breast cancer is of critical importance for treatment planning and the patient’s…
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HER2 testing by Micro-array, resolving tough diagnostic questions

Accurate reporting of HER2 (ERBB2) gene copy number status in newly diagnosed breast and gastric cancers is critical for selecting patients predicted to respond to anti-HER2 therapy. In current clinical practice, tumors are evaluated for HER2 positivity by protein-based immunohistochemistry (IHC) and/or chromosome 17-based fluorescence in situ hybridization (FISH). In the majority of cases, these…
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DRAWING BATTLE LINES OVER LAB TESTS

A year after the FDA proposed regulating “high-risk” laboratory-developed tests (LDTs) along the lines of Class III medical devices, through draft guidances friendlier to for-profit diagnostic developers than nonprofit academic medical centers, both sides have advanced detailed regulatory counterproposals in hopes of swaying the agency. The Association for Molecular Pathology (AMP), whose membership includes academic…
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