23andMe launches redesigned, FDA-authorized direct-to-consumer genetic test – October 22, 2015

Personal genetics company 23andMe announced yesterday that it has launched a redesigned version of its personal genetic test following FDA authorization in February. 23andMe originally marketed a product that allowed consumers to mail in a saliva sample and receive a complete genetic analysis, supposedly indicating their risk for a wide range of diseases and traits. After the FDA placed restrictions on the service in 2013, the company worked with the agency to establish a regulatory pathway for direct-to-consumer genetic testing, which other companies will presumably take advantage of going forward. The centerpiece of the new, narrower product is a “carrier status test” that informs people whether they have a risk variant for one of 36 autosomal recessive disorders. Cystic fibrosis, sickle cell anemia, and Tay-Sachs disease are some of the more familiar conditions on the list. The product also includes more than 60 health, ancestry, wellness, and personal trait reports, a chance to connect with DNA relatives in the database, and reports on genetic research. The product now costs $199, up from $99 originally. As the FDA clears new carrier status tests for other diseases, 23andMe purchasers can access them at no additional cost. While the technology is still a long way off from determining individuals’ risk for complex diseases like diabetes or obesity, the forward-looking Dr. Anne Peters (USC, Los Angeles, CA) sees potential in its ability to shed light on an individual’s drug metabolism and obesity risk. In a recent interview with us, she shared her vision of a future in which genetic testing can help individualize therapy – a bright future indeed! This FDA authorization indicates that the agency is open to individuals taking control of their own health data – a win in terms of increasing patient self-advocacy in our book. Dr. Peters described this narrower version of the test as a good compromise between the previous “free range” of speculation and a complete lack of information. She believes it is a “great start” on the path toward wider associations between genetics and health and disease.  

-- by Helen Gao, Emily Regier, and Kelly Close