The airwaves are buzzing this morning with news of the FDA’s warning letter to 23andMe, the personal-genetic-profile-for-$99 startup, demanding that it “immediately discontinue marketing its Personal Genome Service (“PGS”) until such time as it receives FDA marketing authorization” and warning that “failure to take adequate corrective action may result in … seizure, injunction, or civil money penalties”. You can find the full letter here.
23andMe, which has raised $160 million from prominent venture investors(1), is facing a crisis. Is this a case of bureaucratic hobnail boots trampling a scrappy, innovative digital health start-up? Are we being deprived of the right to know what destiny is written in our personal genetic codes?