Press Releases

WASHINGTON – Last week, Representatives Larry Bucshon M.D. (R-Ind.) and Diana DeGette (D-Colo.) along with Senators Richard Burr (R-N.C.) and Michael Bennet (D-Colo.) reintroduced the Verifying Accurate Leading-Edge IVCT Development (VALID) Act, a landmark bill to assure patients and doctors that their diagnostic tests are safe and accurate while promoting research and innovation in our nation's labs and hospitals. 

What They Are Saying:

AdvaMed President and CEO Scott Whitaker and AdvaMedDx Executive Director Susan Van Meter

“The bipartisan VALID Act is an important step toward the long-overdue modernization of the law for all diagnostic tests. It calls for smart reforms that will incentivize and improve the development of the advanced, reliable tests patients depend on, regardless of where those tests were developed,” said Scott Whitaker, president and CEO of AdvaMed. “We thank Senators Michael Bennet (D-Colo.) and Richard Burr (R-N.C.) and Reps. Diana DeGette (D-Colo.) and Larry Bucshon (R-Ind.)  for their leadership and we look forward to working with them on this important bill.”

“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. “COVID has underscored the necessity of clarity of oversight and transparency for all clinical tests.  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 the bipartisan sponsors of the VALID Act 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.”

American Clinical Laboratory Association (ACLA) President Julie Khani

“ACLA is currently reviewing the VALID Act with our members. As the COVID-19 pandemic has illustrated, a clear and nimble regulatory framework with pathways that do not necessarily impose regulatory burdens on test development is essential to public health and patient care. To best serve patients, laboratories need clarity and certainty in the regulatory environment. This certainty is critical to encourage innovation and the next generation of breakthrough technologies, and to support continued patient access to accurate and reliable laboratory developed tests necessary to diagnose, monitor and optimize the treatment of disease. 

“Over the last several years, ACLA has been working closely with policymakers and other stakeholders to advance diagnostic reform for patients. Specifically, ACLA has consistently advocated for three key priorities: 1) risk-based reform that calibrates regulatory controls to the risk posed by the diagnostic test and which applies standards specific to diagnostics, rather than standards developed for medical devices; 2) appropriate grandfathering and transition policies that preserve patient access to currently available laboratory tests, many of which are currently the gold standard in clinical practice; and 3) a transparent and accountable regulatory system, implemented through notice-and-comment rulemaking, that balances the needs of innovation and appropriate regulatory oversight to ensure the accuracy, reliability and access of these tests. 

“We commend Sen. Michael Bennet (D-CO), Sen. Richard Burr (R-NC), Rep. Diana DeGette (D-CO) and Rep. Larry Bucshon (R-IN), for their continued leadership and attention to this critical issue and look forward to continuing to work together to improve the care available to all Americans.” 

College of American Pathologists (CAP) President Patrick Godbey, MD, FCAP

“As the leader in laboratory quality and improvement programs, the CAP is committed to excellence in the practice of pathology and ensuring patient access to high-quality tests. The CAP appreciates the efforts of Sens. Burr and Bennet, and Reps. DeGette and Bucshon to solicit broad input from multiple stakeholders to produce the bipartisan, bicameral VALID Act. This bill continues to move in the right direction and provides the most viable legislative pathway to reaching a consensus on the oversight of laboratory-developed tests. A legislative approach to oversight of LDTs must leverage existing processes to maintain safe and reliable testing for patients today without stifling innovation of future tests. The CAP looks forward to engaging on the latest version of the VALID Act with the bill’s sponsors, other members of Congress, groups representing patients and other physicians, the US Food and Drug Administration, and the White House as the proposal moves ahead.”

Friends of Cancer Research 

“Friends of Cancer Research (Friends) would like to thank Senators Bennet and Burr and Representatives DeGette and Bucshon for their commitment to patients through the introduction of the Verifying Accurate, Leading-edge IVCT Development (VALID) Act of 2021. By continuing to advance this legislation, which would enable uniform oversight of diagnostics, these members have set a path toward making sure patients and care providers have timely access to high quality tests to inform care. Bennett, Burr, DeGette and Bucshon continue to craft this important legislation in an open, transparent and inclusive way. We appreciate this and look forward to continuing to work toward a final bill. 

“We are pleased with the direction of many of the provisions included in this draft of the VALID Act, importantly: 

• The creation of a technology certification process that supports innovation in test development, performance, and safety. 
• The establishment of an expedited pathway for novel tests used in the diagnosis or treatment of serious conditions. 
• Clarifying FDA’s ability to set standards, which over time would allow the agency to ensure consistent and reliable diagnostic test performance. 

Infectious Disease Society of America President Barbara D. Alexander, MD, MHS, FIDSA

“On behalf of the Infectious Diseases Society of America (IDSA), I write to thank you for your leadership in developing and refining the VALID Act – especially for your ongoing dialogue with stakeholders and efforts to respond to our concerns. In particular, we greatly appreciate your revision to the Humanitarian Test Exemption language, which no longer automatically excludes tests for contagious diseases. We believe this change is crucial to ensure patient access to important tests and is consistent with the bill’s risk-based approach to regulation.

“We look forward to continuing to work with you on this legislation, particularly with respect to the user fees to ensure that academic laboratories remain able to offer testing that is critical to patient care. While we understand that the current bill details a negotiation with key stakeholders, including academic laboratories, to ensure that the user fees are appropriate, we urge Congress to clarify, whether in bill text or otherwise, that this user fee should include provisions to provide small business exemptions, similar to other device user fee programs.

“As we continue to review the legislation, we look forward to opportunities to discuss any remaining questions or issues. As infectious diseases physicians, scientists and public health practitioners, IDSA members know firsthand the importance of rapid, high quality, accessible testing for infectious diseases, and we hope our expertise can continue to be a resource to you.”