Health Care

FDA Clears DNA Test To Spot Cancer Genes, But With Warnings

FDA Clears DNA Test To Spot Cancer Genes, But With Warnings

The Food and Drug Administration just approved an at-home test that allows people to check their risk of breast cancer themselves.

Limited test: There are more than 1,000 known mutations found on BRCA genes, and 23andMe's test doesn't yet look at the most common ones in the general population.

Audio will be available later today. It's the first at-home BRCA1/BRCA2 screening tool to be approved for use in the U.S., and could significantly raise the number of people aware of having the cancer-related mutations.

Erica Ramos, the organization's president, said, "Anyone who has a strong personal or family history of breast or ovarian cancer and is interested in finding out more about their individualized risk should consult with a genetic counselor to discuss their genetic testing options, or to discuss their results".

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 company can report back the three mutations in the BRCA1 and BRCA2 genes that are the most common in the Ashkenazi Jewish population.

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The three mutations detected by the test occur in about 2 percent of Ashkenazi Jewish women, but only 0 to 0.1 percent of other ethnic groups, according to the U.S. National Cancer Institute.

However, this does not find all genes that cause cancer, the FDA cautioned.

Things changed in a big way in 2017 when the FDA authorized 23andMe to provide direct-to-consumer DNA testing for 10 conditions like celiac disease, Parkinson's, Alzheimer's, and more. 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 evaluation, through the FDA's pathway for novel, moderate-risk medical devices, required greater than 99 percent accuracy and repeatability for the assay to be approved.

In that respect, the service could potentially raise a red flag and lead customers to get an additional screen.