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Overview
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 through the USDS DxSTANDARDSTM Process -- standards and methods based on the consensus of regulatory, industry, and academic experts. Analysis is conducted “gold-standard” reference sets of highly qualified clinical samples. USDS evaluates In Vitro Diagnostics (IVDs), Companion Diagnostics, and Laboratory Developed Tests (LDTs), and maintains strict neutrality and confidentiality of all activities and results. USDS customers include pharmaceutical companies, diagnostic manufacturers, laboratories, and payers.

   
 

Background
Under the leadership of then-Commissioner Mark McClellan and Center for Drug Evaluation and Research (CDER) Director Janet Woodcock, the Food and Drug Administration (FDA) created the Critical Path Initiative, whose broad mission was for industry and regulators to agree on best-of-class, standardized methods to help bring therapeutics and diagnostics to the market faster, safer, and with less expense. USDS was founded by Jeffrey Cossman, M.D., President and CEO of USDS, to address an unmet need by providing a standardized process for the independent evaluation of diagnostic tests. USDS, Inc. became a free-standing, independent corporation in Rockville, MD., in 2009. Series A financing was initiated in 2010 by InterWest Partners of Menlo Park, CA.

Services
Development of Diagnostic Tests
• Integrated, standardized process to guide pharma, diagnostic industry, providers, and payers through development, validation, regulatory submission, reimbursement, and commercialization
• Standardized intended use determination and risk assessment evaluation of diagnostics to support regulatory requirements
• Standardized quality and performance evaluation of diagnostics
• Consultation for regulatory and strategic planning
Certification of Tests and Processes
• Certification of test performance to support marketing, approval, adoption, and reimbursement

Core Assets
• Expert panels – leading clinicians and pathologists design studies, define sample sets, and evaluate results in communication with FDA
• Gold-standard clinical samples – clinical sample sets designed by world class pathologists under exclusive agreement with USDS
• World-class laboratory facilities – laboratory partners with specialized capabilities

Stakeholder Benefits
Diagnostic test manufacturers have a trusted partner to independently and confidentially validate their diagnostic tests
Payers can be confident that they are covering reliable and effective tests
Pharmaceutical companies can be assured that companion diagnostics are appropriate and accurate
Clinical reference laboratories can partner to provide valued services
Providers benefit from knowing that tests are valid and provide accurate insight for appropriate care
Regulators have a trusted resource to provide independent analysis derived from expert consensus
Patients can be confident that their tests results are accurate

DxSTANDARDSTM Process
USDS Process
• Documented Standardized Approach
• Key Opinion Leader (KOL) Driven
• Auditable Technical Files
• Regulatory Agency Accepted
• Strict Confidentiality

 
 
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