As laboratory-developed test rule looms, experts warn patients may lose access to critical diagnostics

Healthcare DIVE March 22, 2024
Susan Kelly

In testimony to Congress Thursday, industry and patient group leaders described the trade-offs expected from increased FDA oversight of laboratory-developed tests.

The Food and Drug Administration’s plan to expand oversight of laboratory-developed tests threatens to prevent or delay patient access to innovative diagnostics, industry groups warned in congressional testimony Thursday.

The FDA’s final rule on LDT regulation, which could come as soon as April, has unleashed a fierce debate over how to protect the health and safety of patients by ensuring tests developed in a single laboratory are accurate and reliable but still reach the market quickly. The agency received nearly 7,000 comments on the proposed rule, which would broaden its authority to regulate the tests.

“Laboratory-developed tests really are...

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