Wednesday, April 2, 2008

CLIA? What's that????

You gotta love the shenanigans of these supposed non-clinical SNP Chip testing companies.....Yes, I have decided to call them what they are. They are not Genome Testing companies, they are SNP chip testing companies and guess what? Linda and Anne ran into a buzz saw or maybe revealed their true intentions the other day. Thanks to Daniel over at Genetic Future for pointing this "D'Oh" out......

It turns out that the lab where they had been testing YOUR DNA....Well, not really because when you sent it to them it became THEIR DNA. It turns out that they are not CLIA certified. What is CLIA?

From the Website


  • Congress passed the Clinical Laboratory Improvement Amendments (CLIA) in 1988 establishing quality standards for all laboratory testing to ensure the accuracy, reliability and timeliness of patient test results regardless of where the test was performed.

  • A laboratory is defined as any facility which performs laboratory testing on specimens derived from humans for the purpose of providing information for the diagnosis, prevention, treatment of disease, or impairment of, or assessment of health.

  • CLIA is user fee funded; therefore, all costs of administering the program must be covered by the regulated facilities.

  • Centers for Medicare & Medicaid Services (CMS) (formerly Health Care Financing Administration) assumes primary responsibility for financial management operations of the CLIA program.

The real story....using a non-CLIA certified labs means that no one is held accountable to quality standards or reliability testing. CLIA serves to protect patients.....As Homer would say "D'Oh!"

So anyone who got the 23 and Me test prior to the supposed switch should not be too sure about that Ancestry Painting...And that outlaw streak in you may just not be attributed to the "supposed" link with Jesse James

They say

Though CLIA certification and oversight are appropriate for specific health and disease-related testing, we are complying with these guidelines to be consistent with other types of laboratory testing.

This switch does not affect in any way the nature or quality of the information we provide. We are still using the same technology as before. However, the transition from one lab to another has resulted in delays that are temporarily increasing the length of time it takes to process customer samples.

At no time have we experienced any problems with data quality. We are confident, after comparing genome scans from the previous and new laboratories, that they produce consistent information at greater than 99.9 percent accuracy. That means customers who had their samples processed before the switch will not be at a disadvantage now or in the future.

0.1% isn't that a whole ton of SNPs?????

The Sherpa Says:

Clinical laboratory testing certification is the LAW for health care providers.....Why would 23 and Me need to scramble and use a CLIA certified lab? Hmmmmmmm..........Navigenics? Can you hear me? Me Thinks You have some competition coming........And to the Ladies of Mountain View......Prove It!.....Offer to resequence all the customers who previously tested PRIOR to the switch and then allow them to compare new results with the old results! Oh and New York you need NYS certification too.......Betcha Affy forgot to tell you that.


Andrew Meyer said...

Hey Steve, love the tags or "labels" you use on your posts: Hillary Clinton, Drudge Report & Barack Obama.

That's some good stuff. They should create a post-tagging certification to make sure "labels" are 99.9% accurate.

Peter J. Tonellato, Ph.D. said...

nice proposal. I'll commit to doing the comparison analysis - with any controls and oversight anyone would suggest to impose.

Peter Tonellato
Center for Biomedical Informatics
Harvard Medical School

Steve Murphy MD said...

I'll keep tagging and hoping they read my blog!!! Don't you think that Barack should take a look?

As for Peter.....I think it would be a nice offer. Just to at least clear up any doubt patients may have.

Alberto said...

I didn't understand: the CLIA is a certification that they should have had but didn't have? So how come they sold their products without the CLIA?

Steve Murphy MD said...

If you don't intend your test to be used for medical purposes then you don't need CLIA certification. But in the predisposition for MEDICAL DISEASE testing workd you absolutely need it..