PACIFIC BIOMETRICS N (OTC:PBME)
Industry: Healthcare
Pacific Biometrics, Inc. (PBI), incorporated in May 1996, provides specialty central laboratory services to support pharmaceutical and laboratory diagnostic manufacturers in the conduct of human clinical research, for use in their drug and diagnostic product development efforts. The Company's specialty areas include cardiovascular disease (dyslipidemia, atherosclerosis and coronary heart disease), diabetes (and obesity), and bone and joint diseases (osteoporosis, as well as osteo and rheumatoid arthritis). Coupled with its specialty testing, PBI also has central laboratory capability and provides full-service central laboratory support for multi-center clinical trials, including routine safety lab tests (general chemistry, hematology and urinalysis). The Company's clients include a number of multi-national pharmaceutical, biotechnology and diagnostic companies. Specialty Reference Laboratory Services PBI's specialty reference laboratory is located in Seattle, Washington. The Company's three general areas of expertise include cardiovascular disease (dyslipidemia, atherosclerosis and coronary heart disease); diabetes, metabolic syndrome and obesity; and bone and joint diseases (osteoporosis, as well as osteo and rheumatoid arthritis). PBI offers a variety of services through its specialty reference laboratory, including clinical study testing services, development of laboratory reference methods, development of clinical trial protocols, and contract research and development. As it relates to bone and joint diseases, PBI is active in promoting the standardization of bone metabolism biomarkers, and is involved in technologies for monitoring treatment response in diseases, such as osteoporosis. The Company has used its bone biomarker assays in osteoporosis to manage the first proficiency-testing programs for bone-resorption markers. In the areas of bone metabolism and women's health, PBI specializes in the measurement of hormones, including pyridinolines, various C- and N- terminal telopeptides, procollagens, osteocalcin and bone-specific alkaline phosphatase. Central Laboratory Services The Company's central laboratory services support clinical trials by producing study-specific specimen collection supplies, coordinating collection and the receipt of specimens from clinical sites, processing the samples, generating test databases, and reporting data to sites and sponsors. PBI generally provides full-service central laboratory services in support of Phase I and Phase II United States Food and Drug Administration clinical trials. Technologies and Products During the fiscal year ended June 30, 2004, the Company formed a wholly owned subsidiary, PBI Technology, Inc., for the purpose of holding, developing and seeking commercialization of certain of its technologies and intellectual property portfolio, including its isothermal deoxyribonucleic acid (DNA) amplification method (LIDA), its Cell Viability technology, and its Osteopatch and Saliva Sac diagnostic devices. In August 2002, PBI acquired certain technology from Saigene Corporation, including certain DNA-based technologies, processes and equipment. The Salivasac saliva collection and processing device is developed by the Company, to collect a non-invasive saliva sample that may be able to replace blood and urine testing in various applications. The SalivaSac, which contains a small quantity of a substance that acts as an osmotic driver, is placed in the mouth and rapidly fills with an ultrafiltrate of saliva that is filtered as it passes through the semi-permeable outer membrane. The resulting fluid is clear, easy to use and does not contain interfering substances. The SalivaSac, as a sample collection device, can be combined with existing testing technologies to permit non-invasive diagnostic test applications. The Osteopatch sweat collection device is intended for monitoring markers of bone metabolism. This technology involves a method to measure the presence or absence of markers, typically cross-linked amino acids, such as pyridinoline, from
As Of: 10/07 00:00 ET
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