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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.

 
 
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