FDA’s LDT Proposal Raises Questions About Clinical Validity
Debate is underway on whether current CLIA review of LDTs properly assesses a test’s likelihood to detect diseases.
FDA Proposal for LDTs Risks Serious Consequences
Lab leaders say that the increased level of scrutiny proposed for such tests would be a detriment to innovation and patient care.
Will LDTs Soon Be Regulated?
The FDA recently submitted its own proposed rule relating to lab-developed test regulation for review.
The Diagnostics Pipeline: FDA Proceeds without Congress Over LDTs Reform
The agency recently sent its own proposed LDTs regulation rule to the White House Office of Information and Regulatory Affairs for review.
The Diagnostics Pipeline: FDA Launches Pilot for Cancer Companion Diagnostic LDTs
New program aims to provide greater transparency on the recommended performance characteristics of such tests.