CLIA · CAP · GLP · GCLP
Clinical trial, LDT and GxP testing at PacificDx, our CLIA-certified, CAP-accredited high-complexity laboratory in Irvine, California, backed by the team that develops and validates the assays.
Testing menu
Choose from validated methods, or have us develop and validate an assay for your study.
Targeted panels, TSO 500, RNA-Seq, exome and genome sequencing with validated bioinformatics.
Gene expression, copy number, viral load, vector copy number and rare-mutation detection.
Custom CLIA and GLP panels for immunophenotyping, immune monitoring and receptor occupancy.
ctDNA and cfDNA testing, including TSO 500 ctDNA, for oncology trials and diagnostic development.
ELISA, pharmacokinetic and neutralizing and total antibody (NAb/TAb) assays for nonclinical and clinical studies.
EXO-NET pan-exosome capture from plasma, serum, urine and saliva for biomarker studies.
Testing programs
Central and specialty laboratory testing for sponsors, with sample kits, logistics, project management and data delivery.
Development, CLIA validation and launch of LDTs in our laboratory, with support for MolDX submissions and billing.
Preclinical and clinical studies run under GLP or GCLP, including PK, immunogenicity and biodistribution.
Confidential workflows for assays validated for a single sponsor’s exclusive use.
PBMC processing, nucleic acid extraction and compliant biorepository storage with chain of custody.
Tell us about your samples, volumes and timelines, and we will recommend a testing plan.
Credentials
PacificDx holds federal CLIA certification and CAP accreditation for high-complexity testing, plus clinical laboratory licenses in California, New York, Pennsylvania and Rhode Island.
Our quality system is certified to ISO 13485:2016, and we support supplier audits and quality agreements for sponsors and diagnostic partners.
Share your study design, sample volume and timelines, and we will put together a testing plan and quote.