Leadership at the FDA and the Centers for Medicare and Medicaid Services issued a joint statement to reiterate plans to increase the federal oversight of lab-developed tests, commonly known as LDTs.
Last September, the FDA published a long-expected proposal to bring those types of tests in line with how the agency treats other in vitro diagnostics, with a multi-year timeline that would phase in reviews and other regulatory requirements through 2028.
LDTs had originally been designated a lower-risk category, since they were comparatively less complex tests and typically produced in small volumes by individual laboratories, including many on an as-needed basis. However, LDTs and their uses have evolved in recent years—in both their technology and their nationwide commercial reach, according to FDA and CMS.
“For example, the FDA is aware of tests offered as LDTs that could have led to patients being over- or under-treated for heart disease; patients with cancer being exposed to inappropriate therapies or not getting effective therapies; and incorrect diagnoses of rare diseases, autism and Alzheimer’s Disease,” wrote the FDA’s device center director, Jeff Shuren, and CMS’ acting director of the Center for Clinical Standards and Quality, Dora Hughes, in their joint letter.
“Other evidence, including published literature and the FDA’s experience with tests to diagnose COVID-19, suggests that the situation is getting worse,” they said, adding that physicians today base about 70% of healthcare decisions on lab tests and that the government believes results should be proven to be accurate regardless of where the product is made.
The American Clinical Laboratory Association, the trade group representing diagnostic testing labs, has urged the FDA to withdraw its proposed rule, writing last December that the changes would jeopardize laboratories’ abilities to continue developing new, cutting-edge LDTs.
“The net result of this action would be to reduce patient access to essential testing, including for rare diseases, and hamper innovation in the next generation of diagnostics,” ACLA President Susan Van Meter said in a statement at the time. “Device authorities are rigid and would not allow LDTs to keep pace with scientific advances.”
In its extended comments (PDF) on the FDA’s proposed regulation, the ACLA also pointed to the suite of CLIA regulations that currently apply to accredited clinical labs—which direct them to be staffed by trained personnel and also set down quality requirements and proficiency standards.
In their letter, Shuren and Hughes underlined that CLIA regulates laboratories, not the tests themselves. To show again how the issue has changed, they pointed to a fact sheet (PDF) on LDTs issued by CMS in 2013, which described a “complementary” regulatory approach from the two federal agencies.
“That said, a decade later, in connection with the FDA’s notice of proposed rulemaking, we are—together—reiterating that CMS’s CLIA program is separate in scope and purpose from FDA oversight,” they wrote.
“Some have suggested that concerns with LDTs should be addressed through the expansion of CLIA. This is not the answer,” said Shuren and Hughes, adding that “CMS does not have the expertise to assure that tests work; the FDA does.”
“Both CMS and the FDA believe that patients and their doctors need to know that LDTs are valid. … The FDA and CMS have long stood together in mutual support of FDA oversight of the analytical and clinical validity of LDTs,” they wrote.
Meanwhile, the medical device industry group AdvaMed and its diagnostics division, AdvaMedDx, have supported the FDA’s ability to “clarify the regulatory definition of in vitro diagnostics to encompass tests manufactured within a laboratory setting,” but said in their own submitted comments (PDF) that the public would benefit more from comprehensive diagnostics regulation reform, which would require legislation to be passed by Congress.