U.S. Rep. Larry Bucshon (R-IN) on March 5 introduced bipartisan, bicameral legislation that would federally regulate in vitro clinical tests (IVCTs).
Rep. Bucshon is the lead original cosponsor of the Verifying Accurate, Leading-edge IVCT Development (VALID) Act of 2020, H.R. 6102, with bill sponsor U.S. Rep. Diana DeGette (D-CO), which would create a new product category for diagnostic and lab tests to be reviewed and approved by the Food and Drug Administration (FDA).
“With the help of the VALID Act, the future of precision medicine will enable physicians to provide more individualized patient care to discover, cure, and treat diseases that were previously unknown and untreatable,” Rep. Bucshon said.
If enacted, H.R. 6102 would establish a risk-based approach to IVCT regulation; create a technology certification program for lower-risk tests; require high-risk tests to undergo premarket review to verify analytical and clinical validity; and permit the FDA to require that any test undergo premarket review after providing the developer an opportunity to address issues identified by the agency, according to a summary provided by Rep. Bucshon’s office.
“Advanced diagnostics are transforming the way we provide care for patients in the 21st Century,” said the congressman. “The VALID Act establishes a risk-based regulatory framework that allows for leading-edge development and innovation to thrive, while assuring doctors and patients that their test results are analytically and clinically valid. This will ensure that patients receive the most appropriate medical advice or treatment.”
Additionally, H.R. 6102 would create a new system to allow hospitals and labs to submit their tests electronically to the FDA for approval, a move that would speed up the approval process and increase the quality and reliability of the testing, according to the bill summary.
“What we have learned over the years in successfully combating the spread of viruses, such as MERS, SARS and Ebola, is that time is of the essence,” Rep. DeGette said. “Ensuring that our hospitals and laboratories across the country have the tools they need to quickly and accurately diagnose patients is essential to help prevent the spread of these viruses throughout our communities.”
An identical version of the bill, S. 3404, also was introduced on March 5 by U.S. Sens. Richard Burr (R-NC) and Michael Bennet (D-CO) in their chamber.