Outsourcing to PacificDx
Q: What types of services are available from PacificDx?
As a CLIA certified, CAP accredited and state licensed clinical laboratory, PacificDx provides a wide array of clinical and molecular testing services to bio-pharmaceutical, commercial and clinical laboratories needing to outsource specialty or esoteric testing. Our high-complexity laboratory houses the latest in advanced molecular and non-molecular technologies and expertise to support your specific testing needs.
Q: Where is PacificDx located?
Our Irvine California-based laboratory resides at 5 Mason Lane and is convenient to the nearby John Wayne airport. PacificDx is a wholly-owned subsidiary of ResearchDx and we share the same location. To reach us, please visit our Contact page or email us.
Every project is led by an experienced project manager (PM). The PM, as the central point of contact, will guide, coordinate and manage all project activities, including client communications. Unlike working with multiple partners with multiple points of contact, when unexpected interruptions or delays occur that will impact the IVD development timelines, a CDO can readily adjust with a single phone call to the PM.
Q: What is PlasmaDx?
PlasmaDx is a proprietary PacificDx laboratory service focused on ‘liquid biopsy’ testing for cancer and other disease conditions. Liquid biopsy typically refers to the use of molecular methodologies for diagnostic testing using plasma derived from whole blood samples; however, any human body fluid can be evaluated in this manner. While not all body fluid sampling is a non-invasive acquisition, a minimally-invasive and easily-accessible plasma specimen (liquid biopsy) has proven a valuable advantage in the search for specific biomarkers of disease, particularly in the growing field of cancer diagnostics. Learn more.
Q: What are plasma biomarkers?
Biomarkers are genomic or metabolite components that can be quantitatively or qualitatively measured in plasma. Among a longer list of utilities, their presence or level may indicate a condition or a disease such as cancer; or, may be used to identify candidacy for targeted therapeutic interventions or to monitor a person’s positive or negative response to treatment.
Q: What Testing Services do you offer?
As a high-complexity state-of-the-art credentialed laboratory, we offer a wide range of testing services for both non-molecular and molecular needs. Learn more about our Testing Services if you don’t see what you are looking for, just ask.
Q: What testing technologies do you support?
- Next Generation Sequencing (NGS)
- Qualitative (qRT-PCR) and Quantitative Real-Time PCR
- Flow Cytometry
- Enzyme-linked immunosorbent assay (ELISA)
- Immunohistochemistry (IHC)
Visit Testing Services for specific testing and platforms. Our site describes the more common testing methodologies available — if you don’t see what you are looking for, just ask or give us a call, 949.812.6144.
Specimen Requirements & Shipping
Q: What types of clinical specimens do you accept?
We accept formalin fixed paraffin embedded (FFPE) tissue blocks or slides for genomic profiling of somatic alterations in solid tumors and peripheral whole blood EDTA samples for other molecular and non-molecular analyses. Download our Specimen Guide for more detailed information on specimen preparation. Please feel free to send a test request through our Contact Form by phone at 949.812.6144, or send us an email.
Q: What is specimen shipping process?
Our Specimen Guide provides specific and detailed information for shipping specimens to PacificDx for testing. Should you have any questions or need additional information about shipping your samples, please call us at 949.812.6144.
Q: What are the payment options for outsourcing testing to PacificDx?
We develop a customized services agreement with each client that meets the requirements of the specific testing that is outsourced and the state in which the laboratory is located.
Q: How do I get tested for irritable bowel syndrome (IBS) using the ibs.smart™ test?
To learn how to get this blood test, please visit the Gemelli Biotech website at ibs-smart.com. This site provides the detailed information about the easy process for testing. Your blood sample will be sent to our PacificDx CLIA-certified molecular laboratory in Irvine California where the test will be performed. In partnership with Gemelli Biotech, the ibs-smart blood test is only available through our laboratory.
Q: Can an assay be custom designed to meet my laboratory’s needs?
PacificDx specializes in the design, development, and implementation of high-complexity clinical assays. We are always willing to discuss potential new assays with our clients.