WEST BRIDGEWATER, Mass., Sept. 25 /PRNewswire/ -- Boston Biomedica, Inc. (Nasdaq: BBII) announced today that the United States Patent and Trademark Office has issued the Company a patent covering the use of its proprietary Pressure Cycling Technology (PCT) for the disruption (lysis) of cells, viruses and bacteria. This patent covers a method using certain conditions of temperature and pressure for the essential first step in all genomic (DNA and RNA) diagnostic procedures -- the breaking open of cells and microbes to release nucleic acids. Combined with the patent announced by BBI on September 12, 2000 for the use of PCT with devices for purifying and concentrating nucleic acids, this patent offers BBI the potential to develop a complete PCT system for the lysis, extraction, purification, and concentration of nucleic acids from a variety of cellular, viral and bacterial sources. The first PCT patent, which describes the Pressure Cycling Reactor instrument and methods for controlling enzymatic reactions, was announced by BBI on March 15, 2000.
"The use of Pressure Cycling Technology is a novel approach for preparing nucleic acids and offers several important advantages over existing sample processing methods," said Dr. Mark Manak, Senior Vice President of Boston Biomedica. "PCT is a physical process which minimizes or eliminates the use of harsh detergents and chemicals, often required by other methods, which frequently interfere with the testing process. In addition, the PCT approach may be suitable for extracting nucleic acids from samples that are very difficult to lyse by existing methods, such as relatively resilient plant and animal tissues and bacteria with strongly cross-linked cell walls."
Studies applying PCT to the extraction of nucleic acids from cells, viruses and bacteria, or from tissues and difficult-to-break-open cells, are the focus of two Small Business Innovation Grants (SBIR) awarded to BBI by the National Institutes of Health (NIH) during the past two months, as well as a Cooperative Research And Development Agreement (CRADA) signed with the NIH in August. These studies complement BBI's other major research effort in applying PCT for inactivating pathogens in plasma, funded by yet another NIH SBIR grant and a Research Agreement with the Consortium for Plasma Science, LLC, as announced on September 21, 2000.
Richard T. Schumacher, Founder, CEO, and Chairman of Boston Biomedica said: "Genomic testing is one of the fastest growing areas of medical diagnostics today, with the resulting nucleic acid sample preparation market expected to be approximately $2-4 Billion by 2005. The combination of these newly-awarded patents for the lysis, extraction, purification, and concentration of nucleic acids provides Boston Biomedica with the potential to build a comprehensive proprietary platform for rapid and inexpensive sample preparation, which ultimately may lead to the development of a complete genomic testing system."
"Of further significance to our investors," continued Schumacher, "much of our PCT research and development over the coming months will be funded through recently announced grants and cooperative agreements, thus helping us achieve our stated goal of returning to profitability in the near future, while maintaining a vigorous R&D program for the introduction of new technologies into the in vitro diagnostics marketplace."
BBI acquired PCT in late 1998 and has been developing its potential commercial applications, while concomitantly establishing the infrastructure required to take full advantage of opportunities for implementation. In addition to nucleic acid extraction and the inactivation of pathogens in human plasma, other potential applications include the use of PCT for the pre-treatment of clinical samples prior to testing to protect laboratory workers, food safety, and further genomics applications -- such as nucleic acid sequence analysis.
Boston Biomedica, Inc. provides products and services for the detection and treatment of infectious diseases such as AIDS, Lyme Disease, and Viral Hepatitis. The Company has four business units: (1) BBI Diagnostics, an ISO 9001 certified manufacturer and supplier of quality control and diagnostics reagents 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, management and treatment of infectious diseases.
Statements contained in this news release that state the Company's or management's intention, 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 isolation or virus inactivation; that BBI may never develop a sample preparation method or complete genomic testing system using or based on PCT; or that pressure cycling technology may not be adaptable to any other commercially viable applications. The Company may also not return to profitability in the near future. 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 filing 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 periods ended March 31 and June 30, 2000. Copies of these documents may be obtained by contacting the Company or the SEC.
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CONTACT: Richard T. Schumacher, CEO & Chairman, or Kevin W. Quinlan, President & COO, or William R. Prather, M.D., Sr. VP Finance & Business Dvlp., of Boston Biomedica, Inc., 508-580-1900
