FDA Readies Proposal for Increased Oversight on Lab-developed Tests

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 Journal reported.

Prominent institutions like Mayo Clinic, Laboratory Corporation Of America Holdings LH, and Quest Diagnostics Inc DGX 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.

For nearly a decade, the FDA has urged Congress to pass legislation granting the agency new authority to oversee lab-developed tests.

Some argue that the FDA lacks the legal authority to independently regulate lab-developed tests without legislative support, potentially leading to lawsuits if pursued.

The FDA maintains that it possesses the authority to regulate these tests and believes that the proposed legislative solution, which it still supports, would benefit patients without duplicating the work of other agencies.

Photo by Mufid Majnun on Unsplash