Medicine

First At-Home Genetic Test For Breast Cancer Risk Approved

First At-Home Genetic Test For Breast Cancer Risk Approved

The authorisation allows 23andMe to provide customers with information on three genetic variants known to be associated with a risk for breast, ovarian, and prostate cancer.

"Being the first and only direct-to-consumer genetics company to receive FDA authorization to test for cancer risk without a prescription is a major milestone for 23andMe and for the consumer", Anne Wojcicki, CEO and cofounder, said in a press release.

Donald St. Pierre of the FDA's Office of In Vitro Diagnostics and Radiological Health said in a statement announcing the approval that the test is intended for people who might not otherwise get genetic testing, adding that "it has a lot of caveats". Any person who comes back with a negative for these three gene mutations, for example, could still carry other mutations in the BRCA genes that elevate their cancer risk. But those mutations are not the most common BRCA mutations in the broader population. Notably, the test also examines whether a man is at risk of developing breast and prostate cancers. The use of the test carries significant risks if individuals use the test results without consulting a physician or genetic counselor. Due to the prevalence of other mutations, the test can not determine overall cancer risk, according to the FDA.

Around one in 400 people have BRCA mutations that can cause cancer, and is more common among those with eastern European or Jewish descent.

More news: Wie seals sensational Singapore win

The FDA today granted authorization for a direct-to-consumer test for a highly selected group of cancer-associated BRCA mutations.

The Food and Drug Administration decision is a step forward for the evolving world of consumer genomics. To win approval, the company submitted data showing its instructions and reports are easy to understand.

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. At this time, the FDA is also establishing special controls that outline the agency's expectations for accuracy, reproducibility, clinical performance, and labeling.


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