About RESEARCHDX, INC.
ResearchDx is a diagnostic development company specializing in biomarker discovery, assay development, validation, and regulatory approval, with ISO 13485:2016 certification, CLIA approval, and CAP accreditation. They provide services for diagnostic design, development, and commercialization.
Biomarker discovery for dose selection, patient stratification, diagnosis, prognosis, and therapeutic responseAssay development including PCR, qPCR, ddPCR, NGS, microRNA, protein, flow cytometry, and ELISAAssay validation under GLP, GCLP, CLIA, and NYS standardsOrthogonal testing servicesAnalytical and clinical performance verificationRegulatory approval support including CLIA/CAP validations, Q-Subs, IRB submissions, and device submissionsISO 13485 and GMP-compliant kit manufacturingClinical testing and contract test commercialization
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