ResearchDx, Inc.

ResearchDx is a comprehensive diagnostic development and contract research organization (CRO) specializing in in vitro diagnostic (IVD) test development, validation, and commercialization. The company operates three integrated divisions: Contract Services (biomarker discovery, assay development, regulatory filings); Diagnostic Laboratory (CLIA/CAP/ISO 15189 accredited clinical testing under the PacificDx brand); and Diagnostic Manufacturing (ISO 13485:2016 and GMP-compliant kit manufacturing under the CustomDx brand). Core capabilities include custom molecular assay development (PCR, qPCR, ddPCR, NGS, microRNA, protein, flow cytometry, ELISA), analytical and clinical validation, companion diagnostic development, and complete laboratory accreditation consulting. The company is ISO 13485:2016 certified, CLIA approved, CAP accredited, and FDA registered. Recent achievements include FDA 510(k) clearances for GlutenID celiac genetic health risk test and regulatory approvals for companion diagnostics (ProMarkerD for diabetic kidney disease, FibroSIGHT for MASH liver fibrosis detection). ResearchDx serves pharmaceutical companies, diagnostic startups, and established laboratories requiring integrated IVD development from concept through commercialization and contract manufacturing.