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.
Ask us about Compliance with the NEW FDA LDT -> IVD Regulations
Choose a Laboratory with FDA experience for your next LDT
Our LDT commercialization processes are fully compliant with the New FDA regulations including:
- 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 is our CLIA-licensed, CAP-accredited high complexity clinical testing laboratory. PacificDx is additionally compliant with Good Laboratory Practices (GLP) and Good Clinical Laboratory Practices (GCLP).
PacificDx is fully integrated with ResearchDx and can support your custom pre-clinical, clinical, and post-marketing testing requirements.