23andMe May Be On the Chopping Block

You may have been following the FDA's crackdown on genetic testing company 23andMe.  I know that I have been, as one of over 500,000 individuals who have purchased 23andMe's Personal Genome Service. Anecdotally, I have recommended 23andMe to many friends and colleagues - I really enjoyed seeing my ancestry, risk of disease, and learning more about my DNA.

[23andme.com]

In May, the FDA asked 23andMe, a Google-backed company, for more information about their genetic testing service. When the company failed to reply, last week the FDA ordered 23andMe to stop marketing its genetic test because it said the company has not provided adequate evidence that the tests were accurate. In its warning, the FDA further expressed concerns that patients receiving genetic information without medical guidance might seek unnecessary, and possibly harmful, medical testing or treatment. Interestingly, the FDA's warning letter does not mention that it has received any customer complains about 23andMe's service.

Until this week, 23andMe had not provided comment about the FDA warning letter that leaked  last week. On Tuesday night,  23andMe co-founder Anne Wojcicki finally spoke out. Wojcicki admitted that she failed to respond to the FDA's concern and highlighted a problem with the FDA's approval system. The agency, she said, "is set up to approve individual tests, but 23andMe tests about a million components of a person's DNA. Filing for a million approvals would be impossible."

CLIA Certification

[darkdaily.com]

In addition to needing FDA approval for its genetic tests, 23andMe also had to obtain Clinical Laboratory Improvement Amendments (CLIA) certification from The Centers for Medicare and Medicaid (CMS). All lab testing performed on humans must have CLIA certification. The CLIA Program sets standards for these labs and assigns scores 1, 2 or 3 for each of the following criteria:

1. Knowledge
2. Training and experience
3. Reagents and materials preparation
4. Characteristics of operational steps
5. Calibration, quality control, and proficiency testing materials
6. Test system troubleshooting and equipment maintenance
7. Interpretation and judgment

Click here for more information on CLIA Law & Regulation.