Congress is considering two bills that would regulate lab tests designed in-house, and the senior author of a new study focused on the tests, published in the Journal of Molecular Diagnostics, said he thinks it's warranted.
"I think the FDA has the appropriate standing to help establish tools to regulate complex diagnostic tests," said lead researcher Jochen Lennerz, MD, PhD, medical director of the Boston-based Massachusetts General Hospital Center for Integrated Diagnostics.
The question of regulation is a crucial one, since 70 percent of all medical decisions are based on lab test results.
The two bills in question — HR 4128 and S 1666, or the VALID Act and the VITAL Act, respectively — would be the first pieces of legislation enabling the FDA to regulate lab-designed tests. The FDA did, however, institute two temporary regulations on the tests during the COVID-19 pandemic.
The VALID Act would require a lab to submit data to the FDA on the design and performance of the most complex test it performs. The FDA would then review the test, which represents the lab's entire design-validation process.
The VITAL Act affords labs less responsibility and control for the oversight of such tests, favoring more direct FDA control.
The first temporary FDA regulation on lab-developed tests was in March 2020, when the agency began requiring such tests for COVID-19 to earn emergency use authorization. The first 14 tests were granted authorization an average of 17 days after they were submitted, according to the study.
That requirement was later rescinded in favor of one mandating that makers of the tests submit to a standardized validation for their products' accuracy. That requirement, the study found, revealed that sensitivity levels claimed by test makers were consistently inflated.