The risk of recurrence

Breast cancer test earns FDA approval

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Will the cancer return?

BY Julia Evangelou Strait

A lab testing kit that estimates the risk of breast cancer returning after anti-hormone treatment has received U.S. Food and Drug Administration approval. The technology could help standardize breast cancer diagnosis, according to School of Medicine researchers, who led the 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 four main types by looking at the expression of 50 genes. Each subtype has a distinct genetic signature and requires a different treatment approach.

These subtype data then are combined with a standard pathology variable to deliver a “risk of recurrence” score that predicts the likelihood of that patient’s disease returning within 10 years.

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

“With this test, we are moving toward a standardized diagnosis based on the genetics of the tumor,” said Matthew J. Ellis, MB, BChir, PhD, test co-inventor and oncologist at Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine.

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