Last Wednesday I ate my spinach and dutifully listened in on a brief talk about “The Role of CLIA in the Oversight of Genetic Testing”.

Still with me?

CLIA stands for Clinical Laboratory Improvement Amendments, which is the law and accompanying regulations that cover laboratories that perform patient testing in the US. The regulation of genetic tests is minimal, and the Genetic Alliance has been agitating for a CLIA ‘specialty’ in genetic testing in order to protect consumers (some additional background information can be found here). Drs. Joe Boone and Bin Chen listed the information that laboratories offering these tests would be required to provide (their PowerPoint presentation can be downloaded here). All of the proposed requirements seem unobjectionable. According to Boone, the Department of Health and Human Services will post a notice of this proposed rule in late 2006 or early 2007. Remarkably, these changes were first recommended by the CLIA advisory committee back in 1998. Keep in mind that this will not be a change in law, with all of the legislative horsetrading that goes on; this is simply a new regulation. But it will be at least nine years between recommendation and action. I think the bureaucracy will have to be a bit more nimble if it’s going to keep up with changes in medical genetics, pharmacogenetics, and other areas.