Dive Brief:

• Patient advocacy groups sent a letter to Food and Drug Administration Commissioner Robert Califf on Tuesday asking the agency to develop regulations for laboratory-developed tests if Congress does not pass legislation overhauling how the tests are regulated.
• The signees include watchdog group the Center for Science in the Public Interest, the U.S. Public Interest Research Group, the Center for Food Safety and other groups focused on food allergies and patient safety. 
• U.S. Reps. Diana DeGette, D-Colo., and Larry Bucshon, R-Ind., in March reintroduced the VALID Act (Verifying Accurate, Leading-edge IVCT Development), which would bring lab-developed tests under one regulatory framework with in-vitro diagnostics, but the bill has not yet moved in Congress. 

Dive Insight:

In the past, the FDA hasn’t required premarket review of lab-developed tests, which the agency defines as tests that are designed, manufactured and used within a single laboratory. Before, the tests were relatively simple and had limited availability, such as an in-house test developed by a hospital for a portion of its patients, the FDA said in a statement on its recent activity. 

But as lab-developed tests have gotten more complex, can have broader reach and pose higher risks, the agency has considered changing its approach. The high-profile collapse of blood testing company Theranos in 2016 drove more public attention to the regulatory loophole. 

A bipartisan group of legislators has been working since 2018 to introduce legislation that would change how the tests are regulated. The most recent version of the legislation, called the VALID Act, was reintroduced in the House in March after it was left out of a year-end spending package. 

The bill has won support of medical device groups, including AdvaMed, but has faced pushback from groups including the American Association for Clinical Chemistry and the Association for Molecular Pathology. 

“Ideally, passage of this legislation would provide the FDA with a clear statutory authority to regulate LDTs. However, past experience suggests that such legislation may not pass, especially in the current political climate and given the technical complexity of the issues involved,” the patient groups wrote in a Tuesday letter to Califf. 

If the bill once again does not pass, “it is imperative that the FDA revisit its stance, and take steps to ensure LDTs are accurate and reliable,” the groups wrote. 

The FDA released a draft guidance in 2014 that outlined a risk-based approach to premarket review of lab-developed tests, but that guidance was never finalized.

In their letter, the patient groups said regulation should include requirements for analytical and clinical validation, quality control, adverse event reporting and transparency, which would help “close the gap created by the lack of adequate independent oversight,” and ensure tests that are marketed to consumers and used to treat patients are accurate.