Bicameral, Bipartisan Legislation Creates a Framework for In-Vitro Clinical Tests at the FDA to Ensure Diagnostic Testing Keeps Pace with Medical Innovations
Washington, D.C. – Today, U.S. Senators Michael Bennet (D-Colo.) and Richard Burr (R-N.C.), along with U.S. Representatives Diana DeGette (D-CO-1) and Larry Bucshon (R-IN-8), introduced the Verifying Accurate Leading-Edge IVCT Development (VALID) Act. This bipartisan, bicameral legislation would establish a new paradigm for the review of diagnostic tests, protecting innovation and ensuring that patients can rely on the test results they receive.
“Diagnostic tests are critical to helping patients and their doctors across Colorado make the best decisions for their health care,” said Bennet. “Thanks to American innovation, the diagnostic field is advancing rapidly and informing treatment for the rarest of conditions opening the door to quicker diagnosis and treatment. But as innovation has accelerated, so has the complexity of the tests, begging the need for regulatory reform. Our VALID Act would create a streamlined review process that supports innovation within parameters that protect patients and would provide FDA with tools to support development of new diagnostic tests, improving health care outcomes for all Americans.”
“What we have learned over the years in successfully combatting the spread of viruses, such as MERS, SARS and Ebola, is that time is of the essence,” said DeGette. “Ensuring that our hospitals and laboratories across the country have the tools they need to quickly and accurately diagnosis patients is essential to help prevent the spread of these viruses throughout our communities. This legislation will overhaul the federal government’s outdated system that is slowing down our ability to respond to these threats – and it will ensure that hospitals around the country are able to begin testing patients for these potentially deadly viruses as soon as possible.”
Over the last two decades, diagnostic testing has evolved at a rapid pace. For example, more Americans are purchasing direct-to-consumer tests without the involvement of a health care provider. Although these tests give Americans more information, their results often lack context or guidance on how to best utilize the information.
The growth of diagnostic testing has not been matched with reforms to the regulatory framework, which was established over 30 years ago with the Clinical Laboratory Improvement Amendments (CLIA) of 1988. The VALID Act will modernize the review process for diagnostic testing and clarify the regulatory authority between the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS).
The VALID Act will ensure that the same standards are in place regardless of who is developing the test, giving Americans confidence in their test results while allowing laboratories to develop diagnostic tests – within the same category – without having to pause for additional regulatory review.