“AdvaMedDx has long supported a modernized, risk-based approach to FDA oversight of all diagnostic tests, including laboratory-developed tests (LDTs), as we believe it is imperative that patients have access to accurate and high-quality tests, regardless of where they are made."
“Both the Senate and House have expressed interest in possible legislative approaches to improving regulation for all diagnostic test developers. We believe there are helpful reforms that could be achieved through legislation, and we look forward to continuing to work closely with Congress, FDA, and other stakeholders on any legislative activity."
“We are currently in the process of reviewing the latest House legislative discussion draft—the Diagnostic Accuracy and Innovation Act—released by Representatives Larry Bucshon (R-Ind.) and Diana DeGette (D-Colo.)."
“We applaud the interest of these members in circulating this draft and urge Congress to act on legislation addressing longstanding diagnostic regulatory issues.”