PacificDx—Fully Credentialed Clinical Laboratory

As a premier CLIA, CAP and GLP compliant molecular diagnostics laboratory, PacificDx, provides diverse clinical and non-clinical testing and pathology services to support biopharma, diagnostic and medical professional client testing and IVD development needs. Our collaborative reputation is solidly built on our client’s successes.

Laboratory Capabilities

Supported by experienced scientists and project managers, PacificDx has extensive experience in various technologies, platforms and in-depth understanding of the entire diagnostics pathway from discovery through final commercial product. Our laboratory provides analytical, clinical, esoteric, Clinical Trial, CDx and laboratory consulting services to pharmaceutical, biotechnology and diagnostics companies. 

Full-Service Clinical Trial Support

We maintain a team of project managers, data scientists, clinical laboratory scientists and technicians, and work closely with our Quality and Regulatory groups to ensure flawless execution of your project.

Laboratory Developed Test Commercialization

The Rdx/PDx team are experts in the design, development and validation of LDT assays. We can assist with platform selection, test development, test validation (as defined in 42 CFR §493.14431), commercialization and billing activities required to successfully launch your product.

Regulatory Compliance

PacificDx maintains licensure, accreditation, certification and/or compliance where applicable to pertinent regulatory bodies and to local, state and federal laws. We are flexible to your regulatory needs and can perform testing under our Development protocols, as well as GxP and CLIA regulations.

Protected Health Information (PHI)

This notice of Privacy Practices details how ResearchDx, its employees and volunteers may use and disclose your protected health information (PHI) for purposes of testing or treatment, health care operations, payment, and for other reasons that are allowed or required by law. ResearchDx believes in protecting the security and confidentiality of the information we collect from you. Learn more about our policy.

Learn more about our Clinical Laboratory Services and Consulting.