Who regulates the quality of genetic tests?

I attended two excellent teleconferences sponsored by the Genetic Alliance.

One gave information on CLIA (Clinical Laboratories Improvement Amendment) and CLIAC (the committee who provides recommendations) and the move to implement a genetic testing speciality within its regulation. CLIAC recently gave notice that it will be proposing standards for genetic testing under the CLIA law. CLIAC reviewed all the comments it received on the public notice and is currently formulating a proposed rule to be released for comment at the end of this year or early next year. Learn more about CLIA and about CLIAC.

One of the things explained during the conference was why standards take so long to develop and implement. Rules--the word is a formal one--are the standards that tell how a law will be implemented. For example, the Clean Air Act regulates activities of manufacturers, cities, etc. through a series of rules. The rule proposed through CLIAC (as part of the Centers for Disease Control and the Department of Health and Human Services) will describe how genetics laboratories offering services to the public must function. You probably don't know it, but everytime a physician sends out a sample of your blood for testing, it must go to a CLIA-certified labroatory. So, physicians who send out samples for genetic testing to a CLIA-certified lab are just following the existing general rules about clinical tests. CLIAC's intent is to identify the specific needs of genetic testing that are different from other clinical laboratory testing and functioning.

The ones who don't have to follow the CLIA rules are the ones who receive test requests over the Internet or by phone directly from consumers. If you check the sites advertised along the side of your screen when you check out genetic testing laboratories, you'll find plenty who do not list CLIA certification as one of their qualifications.

The second teleconference I attended discussed information on CETT--the Collaboration, Education, and Test Translation Program from the Office of Rare Diseases (ORD). In May of 2004 this group met for the first time to discuss quality testing for rare genetic diseases. they met last in September 2005 and are currently accepting applications for new genetic tests. Their objectives are to foster the development of new genetic tests, help groups translate tests from research to clinical practice, and educate the public about rare genetic diseases. The special feature of this group is the strong sense of collaboration among clinical laboratories, researchers, and patient advocacy groups. You can learn more about CETT at http://www.cettprogram.org.

The Genetic Alliance helps patient advocacy groups with all aspects of their work, including working with patients, with media, education, obtaining and dispensing funding, and many other opportunities. They are very involved in public policy, as is geneforum, the group sponsoring this website and blog.

Marie Godfrey, PhD

 

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