03.05.20

Burr, Bennet Introduce Legislation to Bring Diagnostic Testing into the 21st Century

Bipartisan, bicameral legislation creates a framework for in-vitro clinical tests at the FDA to ensure diagnostic testing keeps pace with medical innovations

Today, Senators Richard Burr (R-NC) and Michael Bennet (D-CO) introduced the Verifying Accurate Leading-Edge IVCT Development (VALID) Act. This bipartisan 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.

“As the number and complexity of diagnostic tests grow in the U.S., it’s essential we have a regulatory framework that supports innovation and prepares us for the next generation of products,” said Senator Burr. “The VALID Act will do just that by modernizing the review and approval process at the FDA to give diagnostic test developers the ability to keep pace with today’s medical advancements. As a result, test developers will have more transparency and predictability to create tests that discover disease more quickly and help Americans get the care they need. I’m proud to work with Senator Bennet on this important legislation, and I look forward to the Senate’s consideration.”

“Diagnostic tests are critical to helping patients and their doctors across Colorado make the best decisions for their health care,” said Senator 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.”

Background:

Over the last two decades, the landscape of diagnostic testing has advanced at a rapid pace. For example, more Americans are purchasing direct-to-consumer tests without the involvement of a health care provider. These tests give Americans more information, but their results often lack context or guidance on how to best utilize the information.

While the use of diagnostic testing has grown, much of the regulatory framework for these tests 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 the same standards are in place regardless of who is developing the test, and allow laboratories to develop diagnostic tests – within the same category – without pausing for additional regulatory review, and most importantly, give Americans the assurance they need to rely on their test results.

The VALID Act section-by-section can be found here and the bill text can be found here.

Representatives Larry Bucshon (R-IN) and Diana DeGette (D-CO) today introduced identical legislation in the House of Representatives.