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

 
• By Sue Darcey

Clinical labs are troubled by the idea of granting US FDA vast discretion to determine if laboratory-developed tests (LDTs) are analytically and clinically valid, a key feature of the draft US VALID Act, while in vitro diagnostic kit manufacturers want some clarifications and more flexibility written into the proposal for diagnostic regulatory reforms.

Medic staff at work in the laboratory. Background

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 Democrat Michael Bennet is supporting it in the Senate. Both...

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