The FDA has approved a genetic health risk test from genotyping company 23andMe, making it the first test to be marketed directly to consumers for certain conditions.
The decision allows testing for 10 conditions, including Parkinson's disease, late-onset Alzheimer's disease, Celiac disease, hereditary hemochromatosis and hereditary thrombophilia, as well as various deficiencies that could lead to lung and liver disease or organ and tissue disorders.
The FDA said it intends to exempt additional 23andMe genetic risk tests from premarket review and may allow other makers to bypass premarket review after their first notification, potentially setting the market up for competitive direct-to-consumer testing.
The decision opens a much clearer regulatory pathway for companies such as genomics startup Helix to bring these types of testing to the market, Leerink analyst Puneet Souda said in an April 6 research note.
Illumina Inc., the sequencing company that provides testing technology to 23andMe and other companies, also stands to benefit, Souda said. Besides running the majority of current direct-to-consumer testing on its own technology, Illumina holds a 50% share in Helix.
The FDA's decision comes after several years of debate on the agency's role in genetic testing oversight. In November 2013, it issued a warning letter to 23andMe ordering it to halt direct-to-consumer testing for genetic risks. At the time, the administration had not assessed the startup's testing technology and it had not received marketing clearance.
It took two years for 23andMe to gain its first risk authorization, a Bloom syndrome carrier test. The February 2015 marketing authorization opened the door for additional carrier tests to be included without premarket testing, and the company built up its offering to include carrier tests for cystic fibrosis, sick cell anemia and other hereditary conditions.
The FDA was clear that this new authorization and any future ones for the testing would not include function as a diagnostic test, which is often used as the basis for major treatment decisions such as invasive surgeries. Results obtained from the tests should not be used for diagnosis or to inform treatment decisions, it said in its decision.
In a statement, 23andMe said it will release its first set of new genetic health risk reports in April.