CAP leaders met with top officials from the US Food and Drug Administration (FDA) to detail its concerns about the oversight of laboratory-developed tests (LDTs) on May 20. The CAP’s representatives specifically addressed provisions in the bipartisan, bicameral LDT oversight legislation, the Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2020. At present, the CAP believes the VALID Act is the only viable LDT-oversight bill currently being debated in Washington and the CAP’ has sought to improve the legislation. The CAP offered its insights on LDTs and practical issues surrounding the regulation of these tests in its meeting with the FDA.

Representing the CAP were President Patrick Godbey, MD, FCAP; Council on Government and Professional Affairs Chair Jonathan Myles, MD, FCAP; Council on Scientific Affairs Chair Raouf Nakhleh, MD, FCAP; Council on Accreditation Chair Richard Scanlan, MD, FCAP; and CGPA Vice-Chair Joe Saad, MD, FCAP.

Representing the FDA from the Office of the Center were Director Jeff Shuren, Deputy Director for Policy Ellen Flannery, Associate Director for Scientific & Regulatory Programs Elizabeth Hillebrenner, Senior Policy Advisory Brittany Schuck, and Senior Policy Advisor Davina Marano; from the Office of the Chief Counsel were Associate Chief Counsel Marcy Busch and Associate Chief Counsel Sara Beardsley; and from the Office of In Vitro Diagnostics and Radiological Health were Director Timothy Stenzel, Director Personalized Medicine Wendy Rubinstein, Associate Director for Regulatory Programs Toby Lowe, Personalized Medicine Policy Analyst Kristofor Langlais, Personalized Medicine Staff Fellow McKenna Tennant, Associate Director, Guidance, Legislation & Special Projects Eli Tomar, and Senior Policy Advisor Jennifer Tomasello.

Since 2009, the CAP has advocated for a three-tiered, risk-based approach for LDT oversight that leverages a public-private partnership and a targeted role for the FDA.

The CAP has not taken a position on the VALID Act, but the last version of the bill had moved in a positive direction by focusing on the specific issue of LDT oversight and not overreaching to other areas extraneous to this issue. The CAP has advocated that the VALID Act offer flexibility and not be too prescriptive.

The CAP has opposed another bill, Verified Innovative Testing in American Laboratories Act of 2020, concerning LDT oversight led by Sen. Rand Paul, MD (R-KY). Sen. Paul’s legislation is not a viable proposal and lacks support in Congress.

The CAP will remain engaged with the FDA and the sponsors of the VALID Act to advocate for a streamlined, nimbler, and less burdensome approach to LDT oversight.