In vitro diagnostic (IVD) manufacturers have taken key steps to increase patient access to coronavirus diagnostic testing in laboratories, hospitals, and other testing sites across the country to guide patient care and protect public health. Learn which companies have developed IVDs that have received Emergency Use Authorization from the U.S. Food and Drug Administration.
AdvaMedDx supports the establishment, through legislation, of a modernized and predictable, risk-based diagnostics regulatory framework under the Food and Drug Administration (FDA) to which all developers of in vitro clinical tests (IVCTs) would be subject. Under a modernized new framework, Laboratory Developed Tests (LDTs) and In Vitro Diagnostics (IVDs) would be known collectively as IVCTs. The introduction of the Verifying Accurate, Leading-edge IVCT Development (VALID) Act by Sens. Richard Burr (R-NC) and Michael Bennet (D-CO) in the Senate, and Reps. Diana DeGette (D-CO) and Larry Bucshon, MD (R-IN) in the House, is a major milestone toward modernizing IVCT oversight, making diagnostics regulatory reform a reality. The VALID Act would aim to establish a single, diagnostics-specific, risk-based regulatory framework under the FDA for all IVCTs.