Current Genetic Test Regulation Called Unsatisfactory

Experts speaking at a recent conference said government regulation of genetic tests is unsatisfactory and may require a congressional fix.

The government plays a role in regulating the quality of genetic tests, but “there are some important gaps,” according to Kathy Hudson, director of the Genetics and Public Policy Center at The Johns Hopkins University. FDA Deputy Commissioner Janet Woodcock agreed, adding that the current structure of genetic test regulation is “not optimal.”

Most genetic tests are regulated under the Clinical Laboratory Improvement Amendments (CLIA), which have no requirements for proficiency testing, personnel training, quality assurance and quality control of genetic tests, Hudson said, speaking at the Genetic Alliance’s Annual Conference July 28. In addition, there is no genetics specialty under CLIA, limiting quality assurance, the speakers said.