ASCO Submits Comments to Congress on FDA’s Proposed Regulation of 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.”

ASCO’s letter offers responses to questions posed in the committee’s white paper, “A Modernized Framework for Innovative Diagnostic Tests.”

On Jan. 8, ASCO Cancer Research Committee Chair Edward Kim, MD, participated in an FDA workshop intended to obtain feedback on the proposed guidance from medical professionals, patient advocates, insurers and pharmaceutical representatives.

“We are in the midst of a revolution in diagnostic testing where rapid advances are being made in test development while demonstrations of clinical utility are increasingly critical,” Dr. Kim said. “We must take this opportunity to align the data and quality needs with incentives for innovation so that patients and physicians have access to the highest quality, most advanced tests possible.”

ASCO is preparing formal comments to submit to FDA later this month on the proposed guidance.

Source: American Society of Clinical Oncology (ASCO)

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