RECENT DEVELOPMENTS SIGNAL THAT THE FIGHT over FDA regulation of laboratory-developed tests (LDTs) is about to intensify. Last month, two Congressional representatives announced a new bill about LDTs that they said was a “discussion draft.” The bill is titled the “Diagnostic Accuracy and Innovation Act (DAIA).”
It was a big deal in 2014 when the Food and Drug Administration issued draft guidance on a proposed framework for regulatory oversight of LDTs. If it were put into place, this draft guidance would mark the end of the FDA’s historical policy of not applying the medical device regulations to LDTs. Instead, the FDA would implement a risk-based approach for regulation of moderate- and high-risk LDTs.
News of the FDA’s plans to regulate LDTs was met with immediate opposition from the clinical lab industry. Since 2014, FDA officials took measured steps to advance their plan to regulate LDTs. Then, in January, the FDA issued a discussion paper and said it was prepared to work with all stakeholders on how to accomplish its goal of LDT regulation.
FDA regulation of LDTs would be a major development for the clinical laboratory industry. In the past two decades, the number of LDTs that commercial lab companies offers for use in clinical settings has exploded. A large proportion of these LDTs lack adequate clinical data to support the accuracy of the biomarkers they measure and to demonstrate that the test results con- tribute to improved patient care.
Molecular assays and genetic tests are the fastest growing segment of laboratory testing and large amounts of money are involved. The power players in the lab industry would prefer to maintain the status quo for LDTs. At the moment, any lab company can offer any lab test that meets the current definition of an LDT and the user, meaning the ordering physician, must trust that the reported results are accurate and those results are useful in diagnosing the patient and selecting effective therapies.
From that perspective, today’s LDT marketplace can be described as caveat emptor—“let the buyer beware!” Given the money involved in genetic testing, it is likely that there will be bitter fights over any bill, such as the DAIA, that would authorize the FDA to bring LDTs under full or partial regulation.