The Food and Drug Administration (FDA) has outlined a new framework for the review of diagnostic tests to ensure greater clinical and analytical validity.
Currently, the majority of laboratory developed tests (LDTs) used during clinical trials are not reviewed by the FDA, which the agency has described as “concerning”.
In a joint statement Scott Gottlieb, M.D., FDA Commissioner, Jeff Shuren, M.D., J.D., the FDA’s Director of the Center for Devices and Radiological Health, and Lauren Silvis, J.D., Chief of Staff to FDA Commissioner, said LDTs played a critical role in advancing our ability to discover and develop new cures, particularly in a landscape increasingly dominated by targeted therapies.
“Tests that don’t demonstrate analytical and clinical validity, or are poorly designed, can expose patients to serious risks,” said the online statement.
“Patients can be subjected to invasive testing or treatments they don’t need, or delay or forgo further testing or treatment altogether when they need it.”
The new approach will “focus FDA review resources where they would make the most difference and where the risk is the highest”.
Under the plans, a small subset of tests, around 10%, would need individual pre-market approval. These will include novel, higher risk LDTs that are marketed directly to consumers, used at home or are cross-labeled for use with a drug. The process would focus on the analytical and clinical validity of those tests, as well as any unique issues associated with the LDT.
Around 40–50% of LDTs would be subject to a pre-certification program, in which the developer would be evaluated for its ability to design and validate a test.
Manual, low-risk, custom, low-volume, rare disease, forensic, and public health surveillance tests would be exempt from pre-market review, though “appropriate provisions” would allow the FDA to take action to protect patients from harm if needed.
Tests currently being used by clinical labs would be eligible for “grandfather” status and not require review unless undergoing significant changes or a safety issue arose.
“Transparency is a critical component of the FDA’s proposed path forward. It’s remarkable to think that in 2018 we don’t know the full universe of tests that drive our healthcare decisions and contribute to costs throughout the system,” said the statement.
“All stakeholders should have access to information about test developer offerings, performance, claims, regulatory status and adverse events associated with each test. But patients, especially, should be empowered with information about the tests they’re receiving and accurate information that affects their decisions about their own health.”