FDA Seems Poised to Regulate LDTs in Oncology, but Is That a Good Thing?

Published on: 

A panel that discussed the prospect of FDA regulation of diagnostic tests in oncology helped open Patient-Centered Oncology Care November 19, 2015, in Baltimore, Maryland.

This week’s FDA report on the threat to patients when laboratory-developed tests (LDTs) produce bad results appears to be another step toward regulation of these diagnostic tools. But while there’s an argument for more oversight, should it be FDA’s job?

Four panelists took on this question at the first evening of Patient-Centered Oncology Care 2015, presented by The American Journal of Managed Care in Baltimore, Maryland: Scott Gottlieb, MD, a former FDA official now with the American Enterprise Institute; Michael Kolodziej, MD, national medical director, Oncology Strategy, Aetna Inc.; Bruce Quinn, MD, PhD, MBA, a former Medicare official who is now senior director of FaegreBD Consulting; and Joy Larsen Haidle, MS, CGC, president of the National Society of Genetic Counselors.

By definition, LDTs are in vitro diagnostic tools designed, manufactured and used within a single lab; they may have started out as a service, but they have become a commodity. Today, there are strict definitions of what constitutes an LDT, and if several labs form a network to use a test developed by one, that test no longer meets the definition.

Gottlieb said there’s been talk for years of an expanded FDA role in diagnostic testing, but things have picked up steam since the agency issued a draft guidance in October 2014. “FDA clearly thinks it has the authority,” he said, but if they issue final rules, “they clearly will get sued.”

The question, he said, is whether Congress will give FDA more power, or leave most oversight under the purview of the Clinical Laboratory Improvement Amendments (CLIA), within CMS.

Gottlieb and Kolodziej addressed the challenge policymakers face: Customers need confidence that the test they’re paying for is doing the job it’s supposed to do, Kolodziej said, “and most people at present do not think that is occurring.” While Gottlieb agreed that it makes sense to guarantee tests are accurate—to ensure “clinical validity—the FDA by its nature would find it impossible not to venture into questions of “clinical utility,” and that’s not its job.


He believes this, even though FDA has said recently it does not want to regulate clinical utility. For the near term, however, Gottlieb does not expect much change from the FDA, since it’s the end of an administration.

Kolodziej said the important part is that someone ensure that tests are accurate, and if the government fails to step in, then professional societies should. When groups like the National Comprehensive Cancer Network set guidelines in cancer care, “Payers actually pay a lot of attention,” he said.

In the testing realm, standards from the Association of Molecular Pathology (AMP) or the College of American Pathologists (CAP) would carry considerable weight.

Larsen-Haidle agreed that for patients and families, ensuring the validity of tests is “extremely important.”

“In the space of genetics, this impacts the rest of the family, too,” she said.

Quinn said payers haven’t waited on FDA to determine whether tests are worth reimbursing. Years ago, he said, New York State created a laboratory accreditation board that remains in the forefront of other regulatory entities, “by requiring premarket review” of products. Some payers require that tests meet New York state standards before they will pay for them, he said.

“This is where the market is moving, while the FDA is talking about what it might or might not do,” Quinn said.

He also cited the example of MolDx, the unit of the Medicare Administrative Contractor Palmetto GBA that was created to develop expertise in designing reimbursement standards for diagnostic tests.

Gottlieb and Quinn discussed the lack of resources for CLIA, and Gottlieb asked if given enough manpower, could CLIA be “reinvigorated” instead of handing off power to the FDA? Quinn said most likely that CLIA would “outsource” regulation of test accuracy to the professional societies, CAP and AMP.

Kolodziej interjected that regulatory solutions and reimbursement were not the same. “The takeaway message is not, ‘If we solve this regulatory thing, all these tests will be covered.’”

Despite his general wariness about FDA regulation, Gottlieb said certain tests, such as multivariate genetic tests, come closer to a definition of a medical device. These seem to fall outside the CLIA framework, he said, “That’s the part where there should be a healthy debate,” he said.

“Regardless of what happens to regulation, it’s important that patients have access to results that are valid,” said Larsen-Haidle. Transparency in how results are being generated is an important issue in the genetics field, she said.

Quinn said it would have been easier if the United States had a system more like those found in Canada or Europe, where regulators concern themselves with analytic validity—and not with how the test is used.

Said Gottlieb: “I’m not arguing there shouldn’t be a regulatory touch. It’s ‘What’s the appropriate regulatory touch?’”