FDA Readies Proposal for Increased Oversight on Lab-developed Tests - Quest Diagnostics (NYSE:DGX)

The FDA is preparing to increase regulation of a widely used class of tests conducted by laboratories to detect cancer, measure cholesterol, and identify other health issues.

The FDA is developing a proposal to ensure these tests' effectiveness and accuracy.

While the timing of the proposal's release remains undisclosed, this move comes after a congressional bill seeking tighter regulation of such tests encountered obstacles.

However, the FDA's proposal is expected to face significant opposition from the $10 billion industry responsible for developing and conducting these tests, Wall Street Journalreported.

Prominent institutions like Mayo Clinic,Laboratory Corporation Of America HoldingsLH, andQuest Diagnostics IncDGX offer these lab-developed tests, accounting for approximately half of all tests conducted in professional labs.

In contrast to traditional lab tests and FDA-cleared kits, the FDA has not typically regulated these tests, raising concerns that individuals may make crucial health decisions based on potentially unreliable results.