FDA approves first at-home test for cancer risks

FDA approves first at-home test for cancer risks

FDA approves first at-home test for cancer risks

It works similarly to the Company's ancestry test, with the consumer providing a saliva sample which is then analyzed to tell if a woman is at increased risk of developing breast and ovarian cancer, or if a man is at increased risk of developing breast cancer or 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.

The Personal Genome Genetic Health Risk Report was first approved last April to provide information for a broad range of genetic disorders.

Approval of this testing a big step forward in the availability of genetic tests for consumers, but there are more than 1,000 BRCA mutations and this test does not screen for the ones that are most commonly associated with a higher risk of cancer in Americans. "The test should not be used as a substitute for seeing your doctor for cancer screening or counseling on genetic and lifestyle factors that can increase or decrease cancer risk".

"Most BRCA mutations that increase an individual's risk are not detected by this test", St. Pierre said. The FDA expanded that today, adding breast cancer risk testing onto the approved list. During the review of the test, the FDA determined that the data showed the results are accurate and provide reproducible results. Due to the mentioned caveats, the agency indicated that patients should not exclusively rely on this test, nor should the test be used to determine a cancer treatment.

The regulator said it reviewed data for the company's test under a regulatory pathway for low-to-moderate risk devices that are not equivalent to an already marketed device. The test report provides information about the results, how to interpret results, and where additional information can be found, according to the release. At this time, the FDA is also establishing special controls that outline the agency's expectations for accuracy, reproducibility, clinical performance, and labeling.

The FDA granted the marketing authorization to 23andMe.

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