Company Profile

Pacific Biometrics, Inc. (PBI) is a dedicated applied-research facility, providing specialty Central Laboratory Services for clinical research in support of pharmaceutical, biotech, and laboratory diagnostic manufacturers since 1989. PBI specializes in laboratory services for research in lipids and cardiovascular risk, diabetes and metabolic syndrome, as well as bone and cartilage metabolism.

PBI has an established reputation for expertise, flexibility, protocol consultation, and outstanding client services that has propelled the company to a prominent position in the rapidly growing pharmaceutical outsourcing industry. With a global network of scientific, regulatory, and technology expertise, PBI is the service provider of choice for many leading international drug manufacturers in the race to bring products to market as quickly and cost effectively as possible.

PBI provides accurate, reliable analyses, and responsive service to sponsors and investigative sites. PBI collaborates with sponsors to develop, validate, and improve analytical methods, and provides technical consultation for protocol design.

PBI is accredited by the College of American Pathologists (CAP) and the Centers for Disease Control National Heart, Lung, and Blood Institute (CDC-NHLBI) Part III Lipid Standardization Program (LSP). PBI complies with the Clinical Laboratory Improvement Amendments (CLIA) Laboratory Certificate of Accreditation and participates in proficiency programs from CAP, CDC-NHLBI LSP, Accutest Labmetrx Proficiency Testing Program, and NYS proficiency program.

PBI involvement with clients frequently begins at the protocol-design stage. Clinical trial support includes supplying visit-specific collection kits for multi-center studies, coordinating receipt of specimens from investigative sites, processing samples, and timely reporting of consolidated data to study sites and sponsors in a customized format. Extensive knowledge in test development and close collaboration with diagnostic manufacturers allows PBI to provide novel tests for clinical research before such tests are commercially available.

As a specialty provider, PBI excels in measurement of cardiovascular disease markers, especially lipoprotein components, including HDL and LDL, cholesterol (total and free), triglycerides (total and net), phospholipids, apolipoproteins, and so forth. In addition, remnant lipoproteins, Lp(a), and other specialty lipid markers are available. Diabetes testing includes markers such as glucose, HbA1c, GlycoMark™, microalbumin, and non-esterfied fatty acids (NEFA), in addition to lipid markers. In the area of osteoporosis, bone and cartilage metabolism (both RA and OA), PBI specializes in measurement of hormones and biochemical markers, including pyridinolines, various C- and N- terminal telopeptides, procollagens, osteocalcin and bone-specific alkaline phosphatase, cartilage oligomeric matrix protein (COMP), YLK40, and CTX II. PBI also provides routine safety panels for hematology, urinalysis, and general chemistry.

Pacific Biometrics Research Foundation (PBRF) is an affiliated non-profit organization that is one of only three U.S. standardization centers (eleven worldwide) in the Cholesterol Reference Method of Laboratory Network (CRMLN) supported by CDC and NHLBI. As a reference laboratory, PBI has access to reference methods and technologies, thus providing sponsors with unsurpassed quality. PBRF is also experienced in sponsoring interlaboratory proficiency testing programs in lipids and related factors for coronary artery disease, and orchestrated the first interlaboratory proficiency testing programs in bone biomarkers.

PBI supports pharmaceutical and diagnostic companies in clinical trials and provides technical expertise, such as method verification and standardization of assays, for other laboratories.