diagnostic and genomic applications
WEST BRIDGEWATER, Mass., Aug. 8 /PRNewswire/ -- Boston Biomedica, Inc. (Nasdaq: BBII) announced today that it has been awarded a Phase I Small Business Innovation Research (SBIR) grant to use its proprietary Pressure Cycling Technology (PCT) for the extraction and isolation of nucleic acids (RNA & DNA) from viruses in human plasma. The six month $100,000 grant from the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) is designed to demonstrate the feasibility of using this highly innovative approach to improve upon current methods of nucleic acid extraction and purification. BBI believes that PCT offers the potential for greater speed, increased accuracy, fewer handling steps, and lower cost when compared to current methods.
One of the most difficult problems in nucleic acid diagnostics is the extraction and purification of RNA from plasma samples that contain very high levels of certain enzymes (nucleases) that rapidly degrade extracted RNA, thus making the sample useless. This grant will focus primarily on the feasibility of using BBI's PCT procedure to extract and isolate RNA from such samples. During the study, conditions that cycle pressure between high and low levels will be used to simultaneously lyse (break apart) viruses, neutralize their infectivity, release their RNA, and inactivate any nucleases that may be present. In addition to providing improved efficiency, the proposed PCT- assisted RNA extraction and purification procedure eliminates the current requirement for harsh chemical reagents, and could result in substantial savings in both labor and material costs.
According to industry estimates, the size of the clinical market for nucleic acid diagnostics is expected to be approximately $6 billion by 2005, with sample preparation (extraction and purification) accounting for approximately 16-25% of the business. If the research, pharmaceutical and genetics markets are taken into account, industry estimates are that the nucleic acid sample preparation market alone could be approximately $2-4 billion by 2005.
"Current methods for extracting nucleic acids from biological samples are complex and inefficient," said Dr. Feng Tao, Principal Scientist at Boston Biomedica and the Principal Investigator on this grant. "The proposed PCT approach offers the potential to overcome many obstacles to widespread use of molecular diagnostics in both clinical and research settings, as these procedures find ever wider applications in health care."
Dr. Mark Manak, Senior Vice President of BBI, commented, "Although Phase I studies are focused on viral RNA extraction and purification from plasma, the pressure cycling approach is a versatile platform that could be applicable to a broad spectrum of sample types currently considered difficult to process. The success of the proposed technology may benefit not only viral diagnostics, but other areas of infectious disease diagnostics, cancer diagnosis, genomics, forensic analysis, and agricultural applications."
Data obtained in the course of the Phase I study will form the basis of the design of a rapid, automated system for RNA and DNA isolation, which BBI plans to submit for funding in a follow-on Phase II SBIR request. This will include simple, integrated sample preparation devices consisting of disposable extraction units and suitable automated instrumentation designed for either low volume point-of-care testing or high volume testing in a routine or research laboratory setting. This technology may be adaptable for a wide range of sample types, and should allow parallel processing and high throughput, with broad applications in research, clinical and industrial areas. The early design of such a system has already begun at BBI's instrumentation subsidiary, BBI Source Scientific.
The Company acquired PCT in late 1998 and has been exploring its potential commercial applications, while concomitantly establishing the infrastructure required to take full advantage of opportunities for implementation. In addition to sample preparation for nucleic acid testing, potential applications include the use of PCT for inactivation of pathogens in human plasma, food safety, pre-treatment of clinical samples prior to testing to protect lab workers, and applications in genomics such as nucleic acid sequence analysis.
Boston Biomedica, Inc. provides products and services for the detection and treatment of infectious diseases (ID) such as AIDS, Lyme Disease, and Viral Hepatitis. The Company has four business units: (1) BBI Diagnostics, an ISO 9001 certified manufacturer and seller of quality control and other diagnostic products used to increase the accuracy of in-vitro diagnostic tests, (2) BBI Clinical Laboratories, a leading specialty infectious diseases testing laboratory, (3) BBI Biotech Research Laboratories, providing R&D support for the other BBI business units as well as contract research services for third parties, and (4) BBI Source Scientific, an ISO 9001 certified manufacturer of laboratory and diagnostic instrumentation. In addition, the Company is pursuing research and development programs in the areas of Pressure Cycling Technology (PCT) and drug discovery through its subsidiaries BBI BioSeq and Panacos Pharmaceuticals, respectively, with the goal of introducing new solutions for the detection and treatment of infectious diseases.
Statements contained in this news release that state the Company's or management's intentions, hopes, beliefs, expectations or predictions of the future are "forward-looking" statements. It is important to note that the Company's actual results could differ materially from those projected in such forward-looking statements. Factors that could cause actual results to differ from those projected include the possibility that due to difficulties in the development of the technology BBI may not be successful in developing pressure cycling technology into commercially viable products or services, that PCT may never become a better alternative than current methods for nucleic acid extraction and purification, that BBI may not submit a request for Phase II funding or, if submitted, such a request may not be awarded, or that pressure cycling technology may not be adaptable to any other commercially viable applications. There can be no assurance that BBI will be able to complete the design of PCT instrumentation or that such instrumentation will become commercially viable. Additional information concerning factors that could cause actual results to differ materially from those in the forward-looking statements is contained from time to time in the Company's SEC filings, including but not limited to the Company's report on Form 10-K for the year ended December 31, 1999 and on Form 10-Q for the period ended March 31, 2000. Copies of these documents may be obtained by contacting the Company or the SEC.
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CONTACT: Richard T. Schumacher, CEO and Chairman, or William R. Prather, M.D., Sr. VP Finance & Business Dvlp. of Boston Biomedica, Inc., 508-580-1900
