FDA approves first-ever at-home breast cancer test

FDA approves first ever at-home breast cancer test by 23andMe. (Flickr/23andMe)

WEST PALM BEACH, Fla. (WPEC) - For the first time ever, the Food and Drug Administration has approved an at-home breast cancer test.

On Tuesday, the FDA announced it will allow genetic testing company 23andMe to give its customers information about their risk for breast cancer.

According to its website, the company's Health + Ancestry DNA test gives customers a comprehensive look at their genetics and offers more than 75 reports on their ancestry, traits and health.

The test analyzes DNA from a self-collected saliva sample and reveals if a woman is at an increased risk of developing breast and ovarian cancer, and if a man is at an increased risk for breast or prostate cancer. According to the FDA, the test only detects three out of more than 1,000 known mutations. This means a negative result does not rule out the possibility of someone carrying the mutation.

“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 availability of DTC genetic tests," said Donald St. Pierre, acting director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. "While the detection of a BRCA mutation on this test does indicate an increased risk, only a small percentage of Americans carry one of these three mutations and most BRCA mutations that increase an individual’s risk are not detected by this test."

The FDA warns consumer and health care professionals should not use the test to determine any treatments.

In 2013, the FDA stopped the sales of 23andMe's home-testing kits, saying it had failed to prove the validity of the product. The company received approval from the FDA to test customers in 2015 for certain disease-carrying genes that could be passed to children. 23andMe then received approval in 2017 to issue genetic health risk reports.

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