ACMG and AMA Coalition Make LDT Oversight Recommendations to Congress

A coalition of organizations including the American Medical Association (AMA) and American College of Medical Genetics and Genomics (ACMG) have recommended to Congress that oversight of laboratory developed tests (LDTs) be undertaken “primarily through reform of the Clinical Laboratory Improvement Amendments [(CLIA)],” with a more limited role for the Food and Drug Administration. Utilizing a modernized CLIA framework is “the most streamlined and cost-effective” as well as the “least disruptive and burdensome approach,” the coalition asserted. The recommendations suggest CLIA could be modernized by establishing standards for clinical validity and strengthening existing standards for quality control, quality assurance, personnel standards and regular proficiency testing.