In its final report on gaps in the oversight of genetic testing, the HHS Secretary’s Advisory Committee on Genetics, Health & Safety (SACGHS) has urged the Centers for Medicare & Medicaid Services to increase proficiency testing in this rapidly expanding market. The panel also said, in the report released April 30, that the Food & Drug Administration should expand its regulation to all lab tests, including lab-developed tests (LDTs).

In its main FDA recommendation related to clinical validity, SACGHS said the agency should “address all laboratory tests in a manner that takes advantage of its current experience in evaluating lab tests.” In comments on the previous draft, lab and pathology groups argued that the CMS CLIA program should have the lead oversight role for genetic testing, in particular over LDTs, while the FDA should have a consultative role.

But SACGHS said the FDA should exercise this expanded role by consulting “with a multi-stakeholder public and private sector group to determine the criteria for risk stratification and for systematically applying them.” The effort should involve, the commission said, a look at various regulatory models and data sources (for example, New York State, which has the most stringent genetic testing requirements among the states).

For CMS, the advisory commission recommended requiring proficiency testing for an expanded list of regulated analyses. For tests without PT products, labs should use alternative assessment methods, as required under current CLIA rules. The agency also was advised to develop training for inspectors of genetic testing labs. To pay for these initiatives, the CLIA program should be exempt from hiring constraints imposed by or on HHS, the panel noted.

For more on the SACGHS report, see the May 12 issue of the National Intelligence Report.