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- CAP Suggests Ways to Make LDT Oversight Bill Nimbler, Less Burdensome
The CAP suggested several improvements on August 23 to legislation concerning regulatory oversight of laboratory-developed tests (LDTs), which is co-sponsored by a bipartisan and bicameral group of lawmakers.
On June 24, Sens. Richard Burr (R-NC) and Michael Bennet (D-CO), and Reps. Diana DeGette (D-CO) and Larry Bucshon, MD (R-IN) re-introduced the Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2021, which would provide regulatory oversight of laboratory-developed tests if enacted into law. The CAP had engaged with the VALID Act’s sponsors and other stakeholders to suggest enhancements and other changes to the bill over the last year.
The CAP noted that the legislators addressed some issues identified by the CAP in the past. At the same time, the CAP recommended ways to streamline the VALID Act to make it nimbler and less burdensome to implement.
The CAP’s comments on the legislation focused on three specific areas: operationalization, risk classification, and modifications. Read the CAP’s full comment letter on the VALID Act.
In the letter, the CAP said the COVID-19 pandemic, and various challenges stemming from it, brought some stark realities into view. The emergency use authorization (EUA) process, which the CAP agreed needed to be triggered, when coupled with the delayed reviews by the Food and Drug Administration (FDA), allowed the use of several serology tests with performance problems or tests that were poorly validated, the CAP said. The sheer volume of serology tests created pressure on the FDA, producing varying results, and confusion for developers, health care professionals, and patients. In a sense, the CAP said, the country was trading test availability for test quality.
The CAP will further engage with the co-sponsors of the bill and other stakeholders to enhance patient safety, maintain quality laboratory testing, and promote innovation without creating significant regulatory burdens on pathologists and the laboratories they lead.