Diagnostic Testing Services
Introduction
At PacificDx Testing Services, we support many of these leading-edge molecular and non-molecular technologies for diagnostic biomarker interrogation, drug selection targeting, and therapeutic monitoring. These include but are not limited to Next Generation Sequencing (NGS), Enzyme-linked immunosorbent assay (ELISA), Flow Cytometry, and Real-Time PCR and Immunohistochemistry (IHC). If you don’t see what you are looking for, please ask — we are a premier high-complexity molecular laboratory with advanced capabilities.
Our Partnership model
Full Contracted CLIA Commercial Development
ResearchDx can develop, validate, and launch your custom assay technology in our fully approved and accredited facility. We can also provide custom-designed shipping supplies and work with your team on a reimbursement strategy. We can additionally assist with MolDx submissions, billing, and the sale of your test from our CLIA licensed, CAP-accredited Facility.
Pre-Clinical testing under GxP or CLIA
Our development services include:
- PCR,qPCR, RT-QPCR, NGS testing
- 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
We can design, build, and validate dedicated, custom assays to your specifications to meet your clinical trial requirements.
Clinical Trial Assay (CTA) Development
Do you need a custom assay for your clinical Trial or CDx development? RDx can provide custom development, validation of the assay, and complete 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.
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 a 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.