Washington D.C. – Today, Colorado U.S. Senator Michael Bennet and U.S Senator Richard Burr (R-N.C.) and U.S. Representatives Diana DeGette (D-Colo.) and Larry Bucshon, M.D. (R-Ind.) introduced the Verifying Accurate Leading-Edge IVCT Development (VALID) Act. This bipartisan legislation would level the playing field by establishing a new regulatory framework for the review and approval of diagnostic tests, accelerating innovation, protecting public health, and ensuring Americans can rely on the test results they receive.

“Diagnostic tests are integral to patient care and have the potential to save lives and costs to our health care system,” said Bennet. “The rise in diagnostic innovation has produced more complex tests, which require the highest standards to ensure safety. By creating a new FDA regulatory process for diagnostic tests, our VALID Act would protect patients, create certainty to support innovation, and improve health outcomes for all Americans.

“The coronavirus pandemic demonstrated the importance of diagnostic testing, particularly in the nation’s ability to respond quickly and effectively,” said Burr. “Our testing framework must keep pace with today’s medical advancements to better prepare us for the next generation of products to detect diseases and help Americans engage in their health care choices. This legislation will help modernize the FDA review process for diagnostic tests for the first time. By creating a unified framework, we not only give test developers the certainty they need to invest in cutting-edge technologies and products, but also give Americans confidence in their tests results when making critical health care decisions. I’m proud to reintroduce this legislation with Senator Bennet and Representatives DeGette and Bucshon during this historic time.”

“If we’ve learned anything from combatting the spread of highly contagious viruses – such as MERS, SARS, Ebola and now COVID-19 – it’s that time is of the essence,” said DeGette. “We can’t allow an outdated and inefficient system to hold us back when trying to respond to an emerging threat, such as the coronavirus. This legislation will ensure that our hospitals and laboratories have the ability to respond quickly, accurately and efficiently to help us detect and stop the spread of these diseases before it’s too late.”

“In the operating room time is a precious commodity – even the smallest delay can be the difference between life or death for a patient,” said Dr. Bucshon. “Recent advancements in diagnostic testing technology have transformed the speed and accuracy in which doctors receive this life-changing information, giving patients and doctors what they need most: more time. The VALID Act makes sure that a safe, accurate, and risk-based framework is in place to allow leading edge development and innovation to thrive in our hospitals and laboratories, while assuring doctors and patients that their test results are analytically and clinically valid.”

Background:

The landscape of diagnostic testing has advanced at a rapid pace over the last two decades, but there is currently no regulatory framework that assures that tests are clinically and analytically valid. Today, more tests are available to help doctors and patients make health care decisions, Americans are purchasing direct-to-consumer tests, and new tests are being developed at a rapid pace.

While the use of diagnostic testing has grown, much of the regulatory framework for these tests is outdated, having been established more than 30 years ago under the Clinical Laboratory Improvement Amendments (CLIA) of 1988. 

The VALID Act will modernize the review process for diagnostic testing at the Food and Drug Administration (FDA), clarify the regulatory authority between the FDA and the Centers for Medicare and Medicaid Services, limiting duplication between the two agencies. This legislation will ensure the same standards are in place regardless of the test’s developer, allow laboratories to develop diagnostic tests within the same category without pausing for additional regulatory review to foster more innovation, and give Americans the assurance they need to rely on their test results.

The bill text is available HERE. A section-by-section summary is available HERE. A one-page summary is available HERE.