Dive Brief:
- The Food and Drug Administration, which had originally blocked 23andMe in 2013 from marketing a Personal Genome Service, now plans to allow the company to sell a particular test for the rare and inherited Bloom Syndrome directly to consumers.
- At the same time, the FDA announced that it will now classify carrier screening tests as class II and that it plans to exempt them from premarket review. The agency will provide a 30-day period for public comment.
- The announcement does not clear 23andMe to sell a comprehensive set of genetic tests as it did before, Forbes reports, but the company appears to be pursuing that intent. "We remain committed to pursuing a regulatory path for additional tests and bringing the health reports back to the US market," the company states in a press release.
Dive Insight:
The FDA's announcement supports the trend of providing consumers greater control of their healthcare and access to information. The agency states that "in many circumstances it is not necessary for consumers to go through a licensed practitioner to have direct access to their personal genetic information." Carrier screening tests reveal possible gene mutations that could cause people to pass disorders on to their offspring.
The FDA notes that its new stance supports innovation that will ultimately benefit consumers, and that it is taking the same approach as with other over-the-counter products such as tests for pregnancy, cholesterol and HIV.