CLIA · CAP · GLP · GCLP · ISO 13485
Testing, sequencing, cytometry, biorepository and kit manufacturing services from our CLIA-certified, CAP-accredited laboratory and ISO 13485:2016-certified manufacturing operation in Irvine, California.
Our services
Choose from validated methods, or have us develop and validate an assay for your study.
Clinical trial, LDT and GxP testing, including PK, immunogenicity and gene therapy biodistribution.
Targeted and custom 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.
EXO-NET pan-exosome capture from plasma, serum, urine and saliva for biomarker discovery and diagnostics.
Analysis pipelines, reporting and data management for sequencing and biomarker programs.
Compliant sample receipt, processing, storage and chain of custody for clinical and research specimens.
ISO 13485:2016 kit and reagent manufacturing, from design transfer and pilot lots to ongoing supply.
Credentials
PacificDx, our laboratory, 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’ll put together a plan and quote.