The Pew Charitable Trusts and 17 patient advocacy organizations sent a letter to the Senate Health, Education, Labor, and Pensions and the House of Representatives Energy and Commerce committees on June 30 urging them to prioritize diagnostics reform during this Congress by considering the Verifying Accurate Leading-Edge IVCT Development (VALID) Act. The bill, which was introduced on June 24, seeks to bring all in vitro diagnostic tests—including those developed and used in individual laboratories (abbreviated as LDTs)—under one risk-based regulatory system. Under current policy, LDTs are typically not subject to the Food and Drug Administration’s review and reporting requirements, unlike commercially manufactured diagnostic tests. This uneven oversight poses unnecessary risks for both patients and public health and has allowed unreliable tests to reach the market, leading to incorrect diagnoses and treatment.
The VALID Act represents an important step in achieving a unified regulatory framework for diagnostic tests. To that end, the organizations also stated their commitment to working with lawmakers to ensure the legislation addresses concerns from the patient and public health communities. The groups’ shared principles for reform include:
Ensuring health care providers and their patients can trust the results of a test, no matter where it is assembled or performed.
Making sure tests are accurate and provide meaningful information.
Tailoring regulatory oversight to risk levels.
Guaranteeing FDA access to key information about diagnostic tests on the market.
Ensuring FDA enforcement authority is adequate and clear.
Securing sufficient resources for FDA to effectively review tests without unnecessary delay.
Providing the public access to news about diagnostics, including information about test performance and any adverse events.
In addition to Pew, the letter is signed by the American Cancer Society Cancer Action Network, the American Society of Clinical Oncology, Cancer Support Community, Emerson Collective, FORCE: Facing Our Risk of Cancer Empowered, Friends of Cancer Research, Global Liver Institute, LUNGevity Foundation, Lymphoma Research Foundation, Muscular Dystrophy Association, National Center for Health Research, National Consumers League, National Organization for Rare Disorders, Prevent Cancer Foundation, Theresa's Research Foundation, Triage Cancer, and U.S. Public Interest Research Group.