United States Diagnostic Standards (USDS)

USDS, Inc. independently evaluates medical laboratory diagnostic tests to validate quality, speed development, assure alignment with regulatory requirements, guide regulatory pathway strategy, and inform reimbursement decisions. The performance, intended use, and risk assessment of diagnostic tests are certified by standards and methods based on the consensus of regulatory, industry and academic experts. Analysis is conducted utilizing USDS-defined “gold-standard” reference sets of highly qualified clinical samples. USDS evaluates in vitro diagnostics (IVDs) and laboratory developed tests (LDTs) and maintains strict neutrality and confidentiality of all activities and results. USDS is currently partnering with a variety of organizations, including leading global pharmaceutical companies and diagnostic manufacturers.