VALID Act Introduction Advances Diagnostics Regulatory Reform

WASHINGTON, D.C. – AdvaMed President and CEO Scott Whitaker and AdvaMedDx Executive Director Susan Van Meter issued the following statements upon introduction today in the House and Senate of the Verifying Accurate, Leading-edge IVCT Development (VALID) Act for regulatory oversight of in vitro clinical tests (IVCTs) – including in vitro diagnostics (IVDs) and laboratory-developed tests (LDTs):

“It’s time to modernize the law for diagnostics, regardless of where or how they are developed, to keep up with the rapid pace of diagnostic medical technology innovation. The bipartisan VALID Act calls for smart diagnostics regulatory reforms that will incentivize and speed the development of the advanced, reliable tests that benefit the patients we serve,” said Scott Whitaker, President and CEO of AdvaMed. “We thank Senators Burr and Bennet, and Reps. DeGette and Bucshon for their leadership, and look forward to working with them on this important legislation.”

“IVCTs are advancing more quickly than ever, leading to increasingly rapid identification of disease, informing the right treatments for the right patients, and serving as the foundation of personalized medicine that holds great promise,” said Susan Van Meter, Executive Director of AdvaMedDx. “This legislation would allow patients and their clinicians to have the confidence they need that innovative diagnostics of the highest standards will be available to them across the health care delivery system.

“We thank Sens. Richard Burr (R-N.C.) and Michael Bennet (D-Colo.), and Reps. Diana DeGette (D-Colo.) and Larry Bucshon (R-Ind.) for their leadership in introducing this legislation. We look forward to working with them and our partners in the patient, provider and laboratory community to make innovative diagnostics regulatory reform a reality,” Van Meter said.

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AdvaMed member companies produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. AdvaMed members range from the largest to the smallest medical technology innovators and companies. For more information, visit  www.advamed.org.

AdvaMedDx member companies produce innovative, safe and effective in vitro diagnostic tests that facilitate evidence-based medicine, improve quality of patient care, promote wellness, enable early detection of disease and reduce overall health care costs. Functioning as an association within AdvaMed, AdvaMedDx is dedicated to the issues facing in vitro diagnostic companies both in the United States and abroad. For more information, click here.