Dear __________________,

Dear __________________, April 8, 2024 The Honorable Richard Revesz Administrator Office of Information and Regulatory Affairs Office of Management and Budget 725 17th Street, NW Washington, DC 20503 Dear Administrator Revesz, The undersigned organizations support the regulation of laboratory-developed tests (LDTs) by the Food and Drug Administration (FDA) in order to ensure that patients and doct. [...] Historically, FDA has chosen not to exercise its authority to regulate LDTs under the FD&C Act, and as a result, it does not know how many tests are on the market.3 In FDA’s economic analysis of the proposed rule, it estimated that there are approximately 1,200 labs that manufacture LDTs and over 80,000 LDTs on the market, with almost 100 labs entering the market and close to 8,000 LDTs introduced. [...] The estimated benefits of regulation of LDTs were largely based on the health benefits from a reduction in problematic LDTs for COVID-19 and heart disease and the benefits from avoiding payment for inaccurate COVID-19 and non-invasive prenatal tests. [...] The House Energy and Commerce Subcommittee on Health held a hearing on the rule this month in which many of the witnesses and several Representatives supported a legislative approach to the oversight of LDTs. [...] In fact, the one act Congress has taken has been to encourage FDA to finalize its rule for LDT regulation in the House FY24 agriculture appropriations report.9 Moreover, FDA’s proposed rule addresses some of our concerns with the VALID Act in ways that will benefit patients.