GLP · GCLP · CLIA · CAP
Preclinical, clinical, and post-marketing testing at PacificDx, our CLIA-licensed, CAP-accredited high-complexity laboratory that complies with GLP and GCLP standards.
Preclinical & clinical testing
Assays for biopharma and gene therapy programs, run to the quality standard your study requires.
Neutralizing and total antibody (NAb/TAb) assays.
PK assays for nonclinical and clinical studies.
Immune monitoring by flow cytometry.
Enzyme-linked immunosorbent assays (ELISAs).
Viral vector tissue distribution by ddPCR and qPCR.
Editing accuracy and specificity assessed by NGS.
Development & commercial options
Custom development and validation of the assay for your clinical trial or companion diagnostic program, plus sample collection, testing, and project management.
Still in stealth mode, or need an assay validated for your organization only? We set up fully confidential workflows.
Develop, validate, and launch your assay in our accredited facility — with support for MolDX submissions, billing, and selling your test.
Extensive experience with site-specific IVD submissions, with full-service support at your site or ours.
A full-stack service: your own CLIA-certified, CAP-accredited, licensed facility, maintained by our personnel at your site or ours.
Tell us about your study, sample volume, and timeline.
Laboratory-developed tests
In March 2025 a federal court vacated FDA’s 2024 rule on laboratory-developed tests, and FDA formally removed it in September 2025. LDTs continue to be overseen under CLIA, along with accreditors and some states.
Because our team also prepares FDA submissions, your LDT is built so it can move to a 510(k), De Novo, or PMA later if your commercial strategy calls for it.
PacificDx supports custom preclinical, clinical, and post-marketing testing as a fully integrated partner with ResearchDx.