FDA promoting next gen sequencing tests

FDA is considering new steps to stimulate the development of next generation sequencing diagnostics, including the use of third-party databases to support determinations of clinical validity, Commissioner Scott Gottlieb announced Tuesday.

Speaking to the American Clinical Laboratory Association (ACLA) annual meeting, Gottlieb said FDA is “developing policies that will permit more [NGS] tests to be exempt from the burdens of premarket review,” including in some cases allowing marketing of tests based on the manufacturer establishing “initial controls that provide a reasonable assurance of analytical and clinical validity.”...