Breast cancer test developed at Washington University gets FDA approval

See on Scoop.itCancer Research You can Trust

“A laboratory testing kit that estimates the risk of breast cancer returning after anti-hormone treatment has received approval from the U.S. Food and Drug Administration (FDA). The technology is a step toward personalized medicine and could help standardize breast cancer diagnosis around the world, according to researchers at Washington University School of Medicine in St. Louis, who led the test’s development.

The research team, including collaborators at the University of North Carolina, the University of Utah and the BC Cancer Agency in Canada, designed a test that categorizes breast tumors into one of four main types by looking at the expression of 50 genes. The four types are luminal A, luminal B, HER2-enriched and basal-like. Each subtype has a distinct genetic signature and requires a different treatment approach. These subtype data are then combined with a standard pathology variable to deliver a “risk of recurrence” score that predicts the likelihood of that patient’s disease returning within the next 10 years. In this way, clinicians now may be able to accurately identify those low-risk patients for whom standard hormone therapy is sufficient.

The new test removes some of the subjectivity that goes into breast cancer diagnosis, which still involves looking at the cells under a microscope and deciding on likely outcome based on visual cues on how aggressive the tumor is likely to be.”

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