GxP & CLIA Testing Services

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 dedicated 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.

Our LDT Commercialization Meets New FDA Regulations

Choose a Laboratory with FDA experience for your next LDT

Compliance with MDR requirements, correction and removal reporting requirements
Compliance with registration and listing requirements, labeling requirements, and investigational use requirements
Full 21 CFR part 820 compliance
ISO 13485 / GMP Manufacturing Capability
NY-State DOH Licensed and Compliant
Experienced in FDA Pre-submissions and approvals

PacificDx, our CLIA-licensed, CAP-accredited high-complexity clinical testing laboratory, complies with GLP and GCLP standards and, as a fully integrated partner with ResearchDx, supports custom pre-clinical, clinical, and post-marketing testing requirements.