Federal Regulators Discuss DTC Genetic Testing Oversight at AACC Online Meeting | GenomeWeb

Two federal agencies — the US Food and Drug Administration and the Centers for Medicare & Medicaid Services — with oversight of genetic tests are looking into the regulation of direct-to-consumer genetic testing, agency officials said during an online meeting hosted by the American Association of Clinical Chemistry last week.

Judy Yost, CMS' laboratory divisions director, said during the AACC meeting that the agency is "monitoring" DTC labs offering genetic testing to ensure compliance where the Clinical Laboratory Improvement Amendments are applicable.

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