How 23andMe Quelled FDA Concerns About DTC Breast Cancer Gene Test

When the FDA approved 23andMe’s direct-to-consumer test for some BRCA1/BRCA2 gene mutations on March 6, it did so with caveats. The test, which will be wrapped into a larger health-risk test offered by the company, only detects three out of more than 1,000 variants that have been linked to an increased risk of breast, ovarian and other tumors, the FDA noted in its announcement of the approval.

The agency also said it imposed “special controls” on 23andMe to “provide reasonable assurance of safety and effectiveness for this test.” Nonetheless, the approval set off a debate in the medical community about whether the company is acting responsibly in offering a DTC genetic test that could reveal an increased risk of cancer.

Despite the controls that 23andMe has put in place, some healthcare professionals expressed concerns that consumers would take the BRCA test en masse and try to interpret the results without the help of genetic counselors or physicians. “Even with the best explanations, it can be easy to miss that 23andMe is only looking at three different findings [on BRCA], so it’s far from a complete analysis of the BRCA genes,” says Peter Hulick, head of the Division of Medical Genetics at NorthShore’s Center for Personalized Medicine in Chicago.

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Written by Arlene Weintraub for Forbes.