Direct-to-consumer cancer risk test gets FDA approval

08 March, 2018, 01:52 | Author: Lorraine Moran

According to the National Cancer Institute, the three mutations are present in ~2% of Ashkenazi Jewish women compared to 0 - 0.1% in other populations.

"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", said Anne Wojcicki, 23andMe CEO and co-founder, in a press release.

Women with one of these variants have a 45-85% chance of developing breast cancer by age 70.

"Some of the uses for which PGS is intended are particularly concerning", the FDA writes, "such as assessments for BRCA-related genetic risk and drug responses (e.g., warfarin sensitivity, clopidogrel response, and 5-fluorouracil toxicity) because of the potential health consequences that could result from false positive or false negative assessments for high-risk indications such as these". This week, the FDA approved the genetic test by the company, 23andMe, which is part of its $199 Health and Ancestry product.

It doesn't find all cancer-causing genes - not by a long shot, the FDA said.

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About 1 in 400 people have cancer-causing BRCA mutations. The test also does not provide information on a person's overall risk of developing any type of cancer.

BRCA mutations are not the only genetic mutation that raise the risk of breast or ovarian cancer.

The approval comes four years after the FDA threw the brakes on 23andMe's race across the consumer genetic testing landscape in a November 2013 warning letter that amounted to a cease-and-desist order.

"This test provides information to certain individuals who may be at increased breast, ovarian, or prostate cancer risk and who might not otherwise get genetic screening and is a step forward in the ability of direct-to-consumer genetic tests".

The test should also not be used by consumers or health care providers to decide on any treatments, including anti-hormone therapies and preventive removal of breasts or ovaries. Along with this authorization, the FDA is establishing criteria, called special controls, which set forth the agency's expectations in assuring the test's accuracy, reproducibility, clinical performance and labeling.


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