Clinical Diagnostics Consultant – Review DBS Lyme Testing & DTC Business Model
Hourly: $70.00 - $125.00
We are developing a direct-to-consumer at-home testing service that uses dried blood spot (DBS) collection cards for CDC-aligned two-tier Lyme disease testing and optional co-infection panels. Kits will be processed by a CLIA-certified lab using ELISA + immunoblot (IgM/IgG). We are seeking an experienced clinical diagnostics expert to: • Review our proposed testing methodology (DBS two-tier testing) • Identify technical, operational, or regulatory risks • Advise on lab validation requirements (CLIA, LDT, CLEP) • Sense-check the overall business model for scientific and operational feasibility Deliverable: Written memo + 30–45 min live call to discuss findings and answer questions. Ideal Background: • Clinical lab director or consultant with experience in immunoassay validation • Familiarity with DBS testing and LDT frameworks • Experience launching or evaluating DTC diagnostics • Knowledge of U.S. regulatory landscape (CLIA, NY CLEP, CMS)
Keyword: Business Consulting
Price: $70.0
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