Diagnostic Development for Precision Medicine

We Build. Validate. Deliver.

Explore Our Diagnostic Development Services

At ResearchDx, we’re committed to diagnostic design, development, and commercialization. From Biomarker discovery through kit development and regulatory approval, ResearchDx has the expertise and experience to deliver.
biomarker discovery

Biomarker Discovery

Our experience includes developing biomarkers for dose selection, patient stratification, diagnosis, prognosis, and therapeutic response.

assay development

Assay Development

Supporting all test development, including PCR, qPCR, ddPCR, NGS, microRNA, protein, Flow cytometry, and ELISA.

assay validation

Assay Validation

GLP, GCLP, CLIA, NYS Validation. Orthogonal Testing services. Analytical and clinical performance verification

regulatory approval

Regulatory Approval

CLIA/CAP validations, Q-Subs, IRB submissions Class I,II,II device submissions and approvals MolDx submissions

kit manufacture

Kit Manufacture

ISO 13485 and GMP-compliant Kit Manufacturing. Pilot and small Batch Lots, Production Lots, Collection and shipping kits

clinical testing

Clinical Testing

Contract test commercialization. CLIA, CAP/ISO 15189 certification. FDA analytical and clinical validations. Orthogonal Testing

ResearchDx Focus

Custom Assay Development

ResearchDx offers state-of-the-art custom and molecular assay development, from concept and biomarker discovery, through clinical validation and regulatory approval to final kit manufacturing.

Companion Diagnostics

ResearchDx solves the logistical complexities of multi-partner outsourcing for regulated companion diagnostic development. ResearchDx provides all expertise and services within a single, integrated organization.

Laboratory Accreditation

Providing guidance for startups and industry-leading CLIA laboratories. Complete turnkey startup services, including CLIA, CAP, NYS, and ISO-15189 accreditation

Kit
Manufacturing

Customized kit development, including diagnostic, analytical, and OEM assay, contract manufacturing ISO 13485:2016, and GMP compliance to meet your project needs

Choose an Organization with FDA experience for your next LDT

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Diagnostic Laboratory

Diagnostic Manufacturing