ACLA Rejects FDA As A ‘Clinical Validity’ Judge, While AdvaMedDx Seeks Tweaks To VALID Act

Both AdvaMedDx and the American Clinical Laboratory Association agree that it is appropriate for Congress to design a new regulatory oversight framework for laboratory-developed tests (LDTs) and in vitro diagnostic test kits, as was proposed by US lawmakers in a VALID Act discussion draft released in December. But beyond that, the positions of the trade groups for test-kit-makers and commercial laboratories, respectively, on the regulatory reforms for LDTs diverge dramatically in comments submitted to lawmakers on the draft “Verifying Accurate Leading-edge IVCT Development” Act.

Reps. Larry Bucshon, R-Ind., and Diana DeGette, D-Colo., have been backing the proposed VALID Actin the House, while Colorado...