TAG:
Penn Avenue Law and Policy
FDA Reviews Oncology Companion Diagnostics
CEO SUMMARY: Regulatory attorneys indicate that the FDA’s move to reclassify oncology companion diagnostics to Class II medical devices could speed approvals and reduce costs for submissions. From a business perspective, the proposal could allow clinical laboratories to …
FDA Has Future Avenues to LDT Oversight
CEO SUMMARY: Even though a federal court vacated the FDA’s final rule for laboratory developed tests, experts warn that the agency may still be able to regulate some LDTs via its authority over diagnostic software. An attorney notes that software’s central role in mode…
CURRENT ISSUE
Volume XXXIII, No. 2 – February 9, 2026
Congress has once again delayed cuts to test reimbursement rates under PAMA, this time until Jan. 1, 2027. Laboratory professionals are urged to lobby Congress to pass the RESULTS act to solve the PAMA cuts problem permanently. Also, patient-driven testing is spurring new opportunities.
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