Debate is underway on whether current CLIA review of LDTs properly assesses a test’s likelihood to detect diseases.
Lab leaders say that the increased level of scrutiny proposed for such tests would be a detriment to innovation and patient care.
The FDA recently submitted its own proposed rule relating to lab-developed test regulation for review.
The agency recently sent its own proposed LDTs regulation rule to the White House Office of Information and Regulatory Affairs for review.
New program aims to provide greater transparency on the recommended performance characteristics of such tests.