AdvaMedDx Commends Congress for Proposing Comprehensive Diagnostics Reform and Provides Comments on VALID Act Draft Legislation
Washington, D.C.— AdvaMedDx has submitted comments on draft legislation, the Verifying Accurate Leading-Edge IVCT Development (VALID) Act, commending Congress for their support of comprehensive, risk-based diagnostics regulatory reform.
“An overarching, modernized regulatory framework for all diagnostics tests is key to spurring innovation in diagnostics testing for patients and public health,” said Susan Van Meter, Executive Director of AdvaMedDx. “AdvaMedDx applauds Chairman Pallone and Ranking Member Walden, and chief draft authors, Senator Bennet and Representatives Diana DeGette and Larry Bucshon for their dedication to establishing a single, predictable pathway to market under a new regulatory framework that would assure high quality and improved patient access to innovative tests.”
Within its comments, AdvaMedDx appreciated the draft’s commitment to advance a tailored regulatory architecture that recognizes the unique way diagnostics are used in the health care system. AdvaMedDx indicated support for the promise held by a meaningful precertification program for diagnostics, a central tenant of VALID, that aims to promote excellence in quality and help keep the pace of scientific and technological advances while maintaining the highest standard for ensuring analytically and clinically valid tests. AdvaMedDx commended the sponsors’ efforts for a modernized unified approach for all diagnostic tests regardless of where a test is developed, to advance the public health and foster innovation.
Further, in its comments, AdvaMedDx recommends revisions to help ensure clarity in terms and definitions; application of a consistent risk-based framework to IVCT oversight and review; and assurances of public input and public process.
AdvaMedDx welcomed future discussions, with Ms. Van Meter stating, “We look forward to working with Chairman Pallone, Ranking Member Walden, Sen. Bennet, Reps. DeGette and Bucshon, and other members of Congress and stakeholders to ensure that diagnostic testing can meet our most critical current and future health care needs.”
AdvaMedDx member companies produce innovative, high quality in vitro diagnostic tests that facilitate evidence-based medicine, improve quality of patient care, promote wellness, enable early detection of disease and can reduce overall health care costs. Functioning as an association within AdvaMed, AdvaMedDx is dedicated to the issues facing in vitro diagnostic companies in the United States and abroad.