ASCO Backs the FDA on Regulating Lab-Based Diagnostics

In comments to the House Committee on Energy and Commerce, Health Subcommittee, ASCO strongly supported the FDA's resolution to rigorously regulate laboratory-developed tests.

ASCO submitted comments Jan. 5 to the House Committee on Energy and Commerce, Health Subcommittee, strongly supporting the Food and Drug Administration’s proposed risk-based approach to regulation of laboratory developed tests (LDTs).

LDTs are increasingly being used to guide therapy selection for patients with cancer. Failure of such tests to perform as intended can lead to patients receiving inappropriate and potentially harmful treatment, or failing to receive potentially beneficial treatment. ASCO recommends that the FDA regulation be implemented in such manner as to ensure ongoing innovation in the field of molecular testing as well as timely patient access to scientific advances that can improve care.

“In contemporary oncology practice, a patient’s treatment options are increasingly driven by detection of molecular abnormalities in the tumor that drive treatment selection,” ASCO President Peter P. Yu, MD, FASCO, writes in ASCO’s letter to the Congressional subcommittee. “ASCO believes that the tests used to detect those abnormalities must be of the highest quality and thoroughly validated before being offered to doctors and patients. Our patients depend on high quality tests as much as they depend on carefully studied, safe and effective drugs to achieve the best possible outcomes.”

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