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