Well that didn’t take very long.
Five days after the FDA issued a cease and desist letter to 23andme, San Diego resident Lisa Casey has has filed a class action law suit, and she is seeking to represent the “ten or hundreds of thousands” of others across America who paid for the product and were “harmed” because of the “false and misleading claims” about the tests’ ability to provide health information to individuals since 23andMe hasn’t “validated” its interpretive claims with the FDA.
There’s a silver lining here. 23andMe just might decide to litigate whether FDA has jurisdiction over direct-to-consumer genetic testing, and whether the FDA has overreached by classifying their “test kit” as a medical device.
Read more about it here, and here.