PacificDx clinical laboratory
PacificDx provides clinical and non-clinical testing and pathology services for biopharma, diagnostic and medical professional clients, from development studies through commercial testing.
About the lab
Experienced scientists and project managers give PacificDx deep familiarity with a wide range of technologies and platforms, and with the entire diagnostics pathway from discovery to final commercial product.
We provide analytical, clinical, esoteric, clinical trial, CDx and laboratory consulting services to pharmaceutical, biotechnology and diagnostics companies. Our collaborative reputation is built on our clients' successes.
Federal
CLIA Certificate of Accreditation
Accreditation
College of American Pathologists (CAP)
Quality
ISO 13485:2016; GLP and GxP testing available
State licenses
California, New York, Pennsylvania, Rhode Island
What we do
Project managers, data scientists, clinical laboratory scientists and technicians work closely with our Quality and Regulatory groups to execute your study flawlessly.
Platform selection, test development, validation of performance specifications under CLIA (42 CFR §493.1253), commercialization and billing activities to launch your test.
We maintain the licensure, accreditation and certification required by federal, state and local law, and can test under development protocols, GxP or CLIA as your program requires.
Testing at a glance
Sequencing
Illumina TSO 500 (tissue and ctDNA), TruSight Tumor 170, RNA-Seq, miRNA-Seq, exome and genome sequencing.
Custom CLIA / GLP
Custom NGS, qPCR and ddPCR panels, immunoassays, PK assays and flow cytometry panels.
Development
Assay optimization, validation, implementation and full commercialization.
Pre-clinical
PBMC processing, nucleic acid extraction, biorepository storage, antibody binding and neutralization studies, PK assay development.
Patient privacy. Our Notice of Privacy Practices explains how we use and protect protected health information (PHI) for testing, health care operations, payment and other purposes allowed or required by law.
Read our PHI noticeTell us about your assay, sample volume and timeline.