ASCP Responds to Senator Cassidy about Concerns with LDT Oversight

ASCP recently reached out to Senator Bill Cassidy, the senior Republican on the powerful Senate Health, Education, Labor, and Pensions Committee, about laboratory developed test (LDTs) oversight. ASCP’s initiative was in response to the Senator’s request for information on LDT oversight.

ASCP outlined concerns that federal oversight for LDTS “must be rigorous, nimble, and affordable, to ensure laboratories can innovate and provide patients with access to the tests they need.” In contrast, the FDA’s oversight framework, while rigorous, is slow, expensive, and would deter clinical laboratories in hospital and academic medical centers from developing and providing these critical services, ASCP wrote.

While some LDTs have suffered from performance issues, ASCP believes that for the vast majority of LDTs, CLIA modernization is the best way to protect patient care and ensure laboratories can provide access to critical, life-saving laboratory services.

For some diseases and conditions, such as some rare diseases and cancers, LDTs are the only available options for patients, ASCP noted. Some testing services must be adjusted to patients’ unique needs. As such, the FDA’s cumbersome process—whether under the FDA’s proposed rule or the Verifying Access to Leading-edge IVCT Development Act (VALID Act) —could prevent laboratories from offering the services or force them to drastically reduce the number of LDTs they offer. 

Moreover, ASCP noted, under the FDA’s proposed rule, FDA-approved devices that are modified by laboratories may have to go through the cumbersome FDA approval process. Laboratories may make such changes because they discovered, for example, that using a different reagent improved performance or because the requisite supplies were unavailable, and the laboratory was able to get similar performance with alternatives. Yet even under FDA’s proposal, “even the most basic test modifications could require premarket clearance, and this would put treatment decisions and patient care at risk,” ASCP wrote.

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