US DNA testing company 23andMe is seeking regulatory approval for seven of its direct-to-consumer (DTC) genetic tests.
The company have submitted initial stage applications to the Food and Drug Administration (FDA), but have not made details of the applications public. They have said though that the tests under consideration are intended to determine whether individuals carry a disease, are at risk of developing disease, or would respond to certain drugs.
This is the first time that the company has sought regulatory approval for its DTC genetic tests; it has previously argued that the tests are solely for customer information and are not intended for medical diagnostic use.
The application follows the 2010 decision by the FDA that DTC genetic tests which claim to evaluate an individual’s risk of disease count as ‘medical devices’ and thus require regulatory approval (see previous news) and the follow-up warnings it sent out last year to companies offering such tests.
Regulatory approval from the FDA would confer legitimacy on the medical value of the tests. 23andMe co-founder Anne Wojcicki said “FDA clearance is an important step on the path towards getting genetic information integrated with routine medical care”.
Many have raised concerns however that direct-to-consumer genetic tests for disease risk are unable to provide results that can be interpreted or acted upon in any meaningful way by consumers. Last month’s EASAC and FEAM report (see previous news) highlighted this as a key reason for advising people to steer clear of most currently-available DTC genetic tests.
23andMe has said that it intends to submit a further 100 tests to the FDA by the end of next year. Applications will not include the tests it offers for non-medical purposes, such as those for ancestry, since these do not fall under the FDA's jurisdiction.