FDA approves at-home breast cancer gene test

Phillip Cunningham
March 8, 2018

The company can report back the three mutations in the BRCA1 and BRCA2 genes that are the most common in the Ashkenazi Jewish population.

23andMe, a company which uses a saliva sample to analyze DNA, provides information to consumers about ancestry as well as certain genetic health risks. Most breast cancer mutations that increase a person's risk are not detected by this test.

The FDA's director of the Office of In Vitro and Radiological Health, Donald St. Pierre noted that the test has a lot of caveats.

According to a release by the company, the authorization "allows 23andMe to provide customers, without a prescription, information on three genetic variants found on the BRCA1 and BRCA2 genes known to be associated with higher risk for breast, ovarian and prostate cancer". Now they can add information about three BRCA mutations to the health reports they issue. But those mutations are not the most common BRCA mutations in the broader population. The variants also are associated with ovarian cancer in women and breast and prostate cancer in men. Results also should not be used to guide treatment such as surgery or hormones, the FDA said. The test can identify three specific BRCA mutations that occur most often in people of Ashkenazi Jewish descent.

The FDA said that while this test provides detection of a BRCA mutation, only a small percentage of Americans carry one of the variants.

The Food and Drug Administration decision is a step forward for the evolving world of consumer genomics.

"For all these reasons, it is important for patients to consult their healthcare professional, who can help them understand how these factors impact their individual cancer risk and what they can do to modify that risk", the statement continued. They provide information on what the results might mean and where to get additional information.

The FDA reviewed data for the test through the de novo premarket review pathway, a regulatory pathway for novel, low-to-moderate-risk devices that are not substantially equivalent to an already legally marketed device. The agency also outlined special controls created to assure test's accuracy and reliability.

Other reports by

Discuss This Article