CDC's Next Gene-Testing MMWR to Cover Biochemical Testing

By Kirell Lakhman

CDC will focus on biochemical testing in the next installment of its Morbidity and Mortality Weekly Reports dealing with best practices for labs performing genetic tests, according to Judy Yost, director of the division of science at CMS.

Last month, Yost said that beginning with the June 12 MMWR, CDC will publish weekly installments that contain best practices for such labs. Reached by e-mail Monday, Yost, who said CMS played a "large role" in developing the reports, said CDC "has no ETA" for publishing the biochemical testing installment.

The June 12 report amounts to recommendations for best practices in genetic testing for heritable diseases and conditions. It's believed to be the first of its kind penned by the federal government to cover the "accuracy and proper use" of genetic testing.

For that inaugural incarnation, CDC and CMS worked with the Clinical Laboratory Improvement Advisory Committee "to review quality concerns related to molecular genetic testing." The resulting tome therefore claims to comprise "CLIAC recommendations of good laboratory practices for ensuring the quality of molecular genetic testing for heritable diseases and conditions."

Among other findings, the report says that data from earlier studies of clinical lab tests show that "more errors originate during preanalytic and postanalytic phases of testing than during the analytic process itself." For instance, the report defined as "unwarranted" 17 percent of all tests conducted in clinical US labs for the adenomatous polyposis coli gene.