Diagnostics


Health Decisions provides IVD developers with unmatched capabilities for reducing timelines and risk in diagnostics trials.

Health Decisions has conducted successful, efficient IVD trials in a variety of indications and types of IVDs, including molecular diagnostics, immunoassays and others. Our IVD development services offer the design and operational excellence and regulatory expertise required to develop IVDs successfully and eliminate risk of delays in the Premarket Approval (PMA) or 510(k) clearance review process. Health Decisions’ capabilities for helping diagnostics companies make rapid, successful transitions from early sample-collection and validation studies to large subject-based studies are unmatched.

Health Decisions has successfully conducted a variety of large subject-based trials that supported successful PMA and 510(k) submissions, including trials of diagnostics for a variety of oncology indications, STDs, respiratory infections and preterm birth. Our experience includes sample collection, validation, PMA and 510(k) studies and studies involving tissue, blood and urine samples. In addition, our capabilities include end-to-end sample tracking and tracking enrollment by subtypes of results. We understand the importance of obtaining early regulatory agreement on control groups (concurrent or historical), objective endpoints (eliminating bias), quantitative cut points on positive and negative results, and handling of indeterminate results in the statistical analysis.

Experience with Diagnostics Trials

  • HPV molecular diagnostic
  • Colon cancer diagnostics
  • Diagnostics for STDs, e.g. chlamydia, gonorrhea
  • Preterm birth diagnostic
  • Hematology diagnostics
  • Diagnostic for urothelial carcinoma
  • Prostate cancer diagnostic
  • Diagnostic for influenza
  • Diagnostic for fungal infection
  • Sample collection, validation, PMA and 510(k) studies
  • Studies collecting tissue, blood and urine samples