The genetic testing company 23andMe received approval this week from regulators to sell genetic reports on an individual's risk for 10 diseases, most prominently Alzheimer's and Parkinson's. Before you send in your saliva sample and $199, here's what you should know: At most, that you carry a DNA variant that, according to research, is associated with a higher risk of a disease. For the rare clotting disorder hereditary thrombophilia, for instance, the report will say that you do or do not carry a variant called Factor V Leiden in the F5 gene and a variant called Prothrombin G20210A in the F2 gene. If there's enough science to quantify that, the report will specify a percentage, like "your risk is 3 percent." If not, it will just say there's an (unspecified) increased risk.
A logo sign marks the headquarters of 23andMe in Mountain View, Calif., on Jan. 24, 2016. A logo sign marks the headquarters of 23andMe in Mountain View, Calif., on Jan. 24, 2016. Genetic testing firm 23andMe got approval from the Food and Drug Administration last week to sell reports that show customers whether they have an increased genetic risk of developing certain diseases and conditions. The go-ahead is the first time the federal agency has approved such direct-to-consumer genetic tests and comes about three years after the FDA warned Mountain View, Calif.-based 23andMe to stop marketing its health reports because they lacked agency authorization. The company removed health-related results from its genetic tests after this warning, providing only ancestry information and raw genetic data without interpretation.
During Ovarian Cancer Awareness Month (September) and Breast Cancer Awareness Month (October), genetic testing company Color is reducing the price of its new BRCA Test. The test -- which looks for mutations in the BRCA1 and BRCA2 genes that are linked to breast and ovarian cancer -- has a regular price of $149, but for this month and the next, customers can get it for $99. Color already has a test that estimates your risk for hereditary cancers like pancreatic cancer and melanoma as well as breast and ovarian cancers. But the new BRCA Test from Color only looks at the two BRCA genes and estimates risk based on which mutations of the genes you have. This price point puts Color's test below its competitors cost-wise.
Good news for everyone who wants to do at-home DNA tests: 23andMe has been cleared by the Food and Drug Administration to tell customers if they're at risk for 10 potentially debilitating diseases. "These are the first direct-to-consumer tests authorized by the FDA that provide information on an individual's genetic predisposition to certain medical diseases or conditions, which may help to make decisions about lifestyle choices or to inform discussions with a health care professional," the watchdog agency said in a statement. Previously, the FDA had stopped the company from offering this information back in 2013. The FDA softened its stance a bit in 2015. The conditions in question are Parkinson's disease, late-onset Alzheimer's, Celiac disease, Alpha-1 antitypsin deficiency, early-onset primary dystonia, factor XI deficiency, Gaucher disease type 1, G6PD, hereditary hemochromatosis and hereditary thrombophilia.
Photo has been resized and cropped. When the direct-to-consumer genetic testing powerhouse 23andMe was a mere infant, its leaders made a decision that would plunge the company into hot water with the FDA. In 2013, regulators banned 23andMe's $99 at-home assessment for disease risk, citing the potential for incorrect results and their undesirable consequences. Now, at South by Southwest, one of the company's cofounders said 23andMe was indeed in over its head. Linda Avey, who left the $1.5 billion start-up in 2009, told a crowd that 23andMe didn't enough have data to accurately inform people of their genetic risks for certain diseases.