Tuesday, 19 June, 2018

23andMe gets FDA green light for cancer risk test

23andMe kit A 23and Me kit Lydia Ramsey Business Insider
Jordan Brady | 08 March, 2018, 02:18

As geneticist Eric Topol notes on The Verge, the three variants tested here only make up a small percentage of hundreds of known mutations.

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

"Consumers who test positive for these mutations need to be retested in a clinical setting under the supervision of a medical professional before moving forward with any medical decisions", the group said.

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. They're supposed to find and fix mistakes elsewhere in the DNA code. And that can lead to cancer. She works for and mentors other survivors at Carolina's Breast Friends, an organization which provides compassion and support to people going through breast cancer.

These variants are most prevalent in those of Ashkenazi Jewish descent, and have been observed at much lower rates in other ethnicities, according to the FDA.

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

The three variants in the BRCA1 and BRCA2 genes are associated with a significantly higher risk of breast and ovarian cancer in women, and breast cancer in men.

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

In a reversal of fortune for 23andMe, the US Food and Drug Administration (FDA) has granted the company the first-ever authorization for direct-to-consumer genetic testing for cancer risk without a prescription. "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. The company submitted data on user comprehension studies, using representative GHR test reports, that showed instructions and reports were generally easy to follow and understood by a consumer.

The test, from 23nMe, analyzes DNA from saliva collected by clients, the FDA said in an agency news release.

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