AACC to FDA: Don’t Regulate LTDs to Death

January 30, 2015

The American Association for Clinical Chemistry said Thursday that it shares the FDA’s goal of improving the safety and efficacy of laboratory-developed tests, but that the agency should limit its oversight to higher-risk LDTs that could pose a serious risk to patients if inaccurate.

AACC also recommends that the FDA broaden its criteria for tests for rare diseases that are exempt from regulatory review and reevaluate a proposal to discontinue or review tests that satisfy unmet clinical needs once the agency clears or approves a similar test. The industry group has submitted its recommendations to the agency.

LDTs currently are regulated by the Centers for Medicare & Medicaid Services — a process AACC said is sufficiently rigorous. However, due to the growing number and complexity of LDTs, the FDA issued draft guidance last fall proposing that high- and moderate-risk LDTs be subject to premarket review.

AACC urges the FDA to gather data on LDTs that labs currently use before finalizing its proposed regulatory framework.  — Kellen Owings