23andMe founders Anne Wojcicki and Linda Avey (in their traditional, somewhat eye-hurting fluorescent pink attire) have now used the 23andMe blog The Spittoon to apologise and explain. It seems that the company has changed the lab used to perform their genotyping, and the transfer has resulted in an inevitable lag time.
Bearing in mind that 23andMe are at the forefront of a brand new industry involving complex technical and legal issues, such delays are not unexpected. It appears in this case that the change of lab was driven by regulatory requirements; the new lab is certified under the Clinical Laboratories Improvement Act of 1988 (CLIA).
I don't know enough about the regulatory environment in the U.S. to guess at whether this move is simply in order to stay ahead of the shifting demands of regulatory agencies, or whether it heralds a move towards a more clinical focus (something the company has explicitly steered away from so far). Any thoughts?
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4 comments:
Daniel,
In the health care environment in the United States, not using a CLIA certified lab is ILLEGAL!!! Yet another reason whay hastily created companies should be viewed with caution. This is a classic rookie mistake that could have been avoided if there were physicians and laboratory scientists at the helm over there in Mountain View. Don't ever send ANY genetic testing out in the US unless the lab is CLIA certified. What's CLIA? see here
http://www.fda.gov/cdrh/clia/
-Steve
www.thegenesherpa.blogspot.com
Thanks Steve,
Looks like I have some reading to do!
So 23andMe's emphatic advice to their customers that their information is not diagnostic was designed to skirt around the CLIA definition of a lab as being "for the purpose of providing information for the diagnosis, prevention, treatment of disease"?
I guess the change of facilities will sort that out, but then what are the legal implications of having already dispensed information that customers might perceive as diagnostic (despite the disclaimers) from a non-CLIA-certified lab?
For the record, it's not illegal to offer genetic testing without CLIA certification but it won't be reimbursed by MediCare. Since these tests are not reimbursed anyway it doesn't really matter.
The real issue is that the stringent protocols necessary to get CLIA certification can reduce technical errors in the lab. This is going to be a major issue when the public starts making important clinical decisions based on dubious claims. Having CLIA certification removes one of the quality assurance variables at least.
Tim,
It IS ILLEGAL to send a medicare patient's sample to a lab which does not have CLIA certification. You even have to get approval to send specimens overseas for analysis. Even labs cannot test medicare samples if they do not have certification. See Below...
"Every site in the United States that conducts tests on human specimens for diagnosis, treatment or health assessment is required to hold the appropriate type of CLIA certificate. The regulation requires certification of all sites conducting any clinical test including those considered simple and without regard for payment to comply. Beyond it being illegal for laboratories that do not hold CLIA certificates to conduct tests , Medicare and Medicaid laboratory reimbursements are denied when appropriate certificates do not exist."
http://www.cdphe.state.co.us/lr/Certification/index.htm
-Steve
www.thegenesherpa.blogspot.com
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