Monday, 24 September, 2018

FDA gives nod to 23andMe for no-prescription breast cancer gene testing

VIDEOSTOCK VIDEOSTOCK
| 08 March, 2018, 02:16

The genetic testing company 23andMe has won approval from the US Food and Drug Administration to sell a test directly to customers that detects DNA mutations associated with a higher risk of several cancers. As geneticist Eric Topol notes on The Verge, the three variants tested here only make up a small percentage of hundreds of known mutations.

Of course, the test shouldn't be taken as the be all, end all of cancer risk - nor is it meant as a replacement for a proper screening.

The test is fairly straightforward.

However, this does not find all genes that cause cancer, the FDA cautioned. Now they can add information about three BRCA mutations to the health reports they issue. And FDA warned that the tests, which work by analyzing saliva samples, carry significant risks for individuals if they are used without consulting a doctor or genetic counselor.


Genetic testing powerhouse 23andMe announced today that it's officially received the FDA go-ahead to launch a direct-to-consumer testing kit for genes linked to various forms of cancer.

The three variants of the gene are found most often in people of Ashkenazi Jewish descent, with one in 40 people of that background carrying one. 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. But they're most common among people of Eastern European Jewish descent. "Together, BRCA1 and BRCA2 mutations account for about 20 to 25 percent of hereditary breast cancers and about 5 to 10 percent of all breast cancers", the National Cancer Institute says.

Granted to 23andMe, the authorization covers the Personal Genome Service Genetic Health Risk Report for BRCA1/BRCA2 (selected variants).

The FDA stressed that consumers and health care professionals should "not use the test results to determine any treatments, including anti-hormone therapies and prophylactic removal of the breasts or ovaries". The agency also outlined special controls created to assure test's accuracy and reliability.

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