Fierce Biotech January 19, 2024
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...
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