Overview
United States Diagnostics Standards (USDS) is a private independent
review body for medical diagnostics — providing third-party
certification and evaluation of diagnostics for pharmaceutical
companies, diagnostic manufacturers, clinical laboratories, and
payers. We provide evaluation and certification to support
standardization, quality and development and to inform approval,
reimbursement and adoption of diagnostics. USDS' rigorous systems
help to ensure that diagnostics serve their purpose of accurate
diagnosis and patient management — ultimately improving health
outcomes for patients.
Background
USDS certifies the performance, clinical use, and risks of
diagnostic tests through its DxSTANDARDS™ process, using
standards and methods based on the consensus of leading independent
experts in medical diagnostics and clinical medicine. Analysis is
conducted by experts using “gold-standard” reference sets of
highly qualified clinical samples and careful study design. We
evaluate in vitro diagnostics (IVDs), companion diagnostics, and
laboratory developed tests (LDTs) — maintaining strict
neutrality and confidentiality of all activities and results. USDS
serves pharmaceutical companies, diagnostic manufacturers, clinical
laboratories, and payers. We are recognized as a qualified independent
review body for Medicare coverage in the Palmetto MolDx program.
USDS was founded in 2009 by Jeffrey Cossman, M.D., President and
Chairman. The company's lead investor is InterWest Partners and
includes Dr. Mark McClellan among its advisors.