The Verifying Accurate Leading-edge IVCT Development (VALID) Act has been floating around Capitol Hill for the past four years, but was once again left by the wayside when Congress passed the latest ...

The 2024 election results will have vast consequences for health policy, but one of the less visible effects will be to once again disrupt how the federal government regulates diagnostic tests.

Laboratory-developed tests (LDTs) constitute a class of diagnostic in vitro tests that are designed, manufactured, and used within a single laboratory. The Food and Drug Administration (FDA) has long ...

Healthcare issues related to clinical laboratories; H.R. 2377/S. 1000, the Saving Access to Laboratory Services Act (SALSA), provisions relating to reform of Medicare reimbursement for clinical ...

While some proponents of the bill still hold out hope for the VALID Act, others said it’s unlikely to get traction again anytime soon. Several of those involved said they anticipate the FDA, which has ...

Members of a House committee mostly agreed that laboratory-developed tests need more oversight, but were divided Thursday on how best to approach the topic. The issue at hand was a proposed rule from ...

ROCKVILLE, Md. – Dec. 23, 2022 – The Association for Molecular Pathology (AMP), the premier global, molecular diagnostic professional society, today applauded Congress for reaching an agreement on the ...

Congress has wrapped up the budget for fiscal year 2023 with yet another significant boost to funds for the National Institutes of Health, but the omnibus legislation also authorizes the U.S. FDA to ...

Healthcare issues related to clinical laboratories; H.R. 2377/S. 1000, the Saving Access to Laboratory Services Act (SALSA), provisions relating to reform of Medicare reimbursement for clinical ...