Pre-Clinical testing under GxP or CLIA

• Neutralizing antibody/total antibody (NAb/Tab) assays
• PK Assays
• Immune monitoring by flow cytometry
• Sensitive analyte measurement using enzyme-linked immunosorbent assays (ELISAs)
• Gene Therapy: Viral tissue distribution via ddPCR, qPCR
• Gene Editing Therapy: Assess gene editing accuracy and specificity via NGS

CTA Assay Development

Need a custom assay for your clinical Trial or CDx development? RDx can provide custom development, validation of the assay, and full clinical trial sample collection, testing, and project management services

Proprietary Validation and Testing

Still in stealth mode, or need an assay validated for use by only your organization. No problem, RDx can setup completely confidential workflows, ensuring absolute privacy.

Full Commercial Development

• A list of our current licenses and accreditations may be found here
• A list of the technologies supported by our laboratory may be found here
• A list of our NGS testing Capabilities  supported by our laboratory may be found here
• A list of our QPCR and ddPCR testing Capabilities  supported by our laboratory may be found here
• A list of our Flow Cytometry testing Capabilities  supported by our laboratory may be found here

ResearchDx can develop, validate and launch your custom assay technology in our fully approved and accredited facility. We can additionally assist with MolDx submissions, billing and sale of your test from our CLIA licensed, CAP accredited Facility.

Site specific 510(k) and PMA

RDx has extensive experience in submitting site-specific IVDs. We can provide full-service submissions at your site or ours.

Contract Laboratory Development

Need your own commercial facility? RDx can provide a “Full stack” contracted service, providing you with your own CLIA-approved CAP-accredited licensed facility maintained by RDx personnel and located either at your site or ours.