A Better Test for HER2 Status? Not Yet.

The false-negative rate of Oncotype DX qRT-PCR was >50%.

The human epidermal growth factor receptor 2 (HER2) gene confers its cancer-inducing effect by amplification that results in mRNA overexpression and, ultimately, protein overexpression. The Oncotype DX assay (Genomic Health, Inc. [GHI]) is a validated, FDA-approved multigene assay that provides a recurrence score to assist clinicians in predicting prognosis in patients with estrogen receptor–positive, axillary node–negative breast cancer. Using quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) technology, GHI has begun to report separate HER2 results in addition to recurrence scores.

Immunohistochemical (IHC) and fluorescence in situ hybridization (FISH) assays remain the independently validated tests for assessing HER2 …

Reviewing Author

William J. Gradishar, MD

Disclosures

Consultant/Advisory BoardLilly; AstraZeneca; Gilead

Grant/Research SupportBreast Cancer Research Foundation

Editorial BoardsClinical Breast Cancer; Oncology; Annals of Surgery; Breast Cancer Research and Treatment

Leadership Positions in Professional SocietiesNational Comprehensive Cancer Network (Chair, Breast Cancer Panel); American Board of Internal Medicine (Medical Oncology Board)