Diagnostics Development Support & Services

By offering a comprehensive range of in vitro diagnostic services, we augment or integrate your project needs through outsourcing to a single partner. If you don’t see what you need just ask, and we can tailor any of our services to your specific needs.


  • Biomarker discovery (molecular, protein, other)
  • Assay/kit development and validation
  • Platform evaluation and automation
  • Studies to establish biological baseline
  • Broad, multi-platform technology capability (no bias)
  • LDT/custom development/clinical validation

  • Complete clinical trial services, program management and support
  • Clinical trial strategic consulting
  • Reference trial testing services
  • Clinical primary site testing
  • Analytical and clinical testing
  • Complete data management program support

  • Strategy and FDA interactions
  • IVD PRE-IDE, PMA and 510(k) filings
  • International regulatory filings
  • Compliance auditing and consulting
  • Compliant labeling
  • Software documentation
  • Third party review by Accredited Persons (AP)

  • Custom reagents, assays, or final kits for research, clinical, final product
  • Molecular/non-molecular IVD development
  • OEM reagents, kit components or assays
  • Certificates of Analysis (COA)
  • Sample collection kits

  • CLIA, CAP, ISO, GLP, state and regulatory certification, accreditation and compliance
  • High-Complexity specialty testing resource (molecular/non-molecular)
  • Broad, multi-platform capability (no bias)
  • Pre-inspection auditing/readiness
  • Complete resource and consulting for new start-up
  • Mock inspections (CLIA, CAP, ISO)
  • Inspection audit responses (CLIA, CAP, ISO)
  • Provision of standard laboratory documentation (CLIA, CAP, ISO compliant)

  • Non-clinical testing
  • Pre-clinical testing
  • GLP compliance consulting