Patent Addresses Key Aspects of Nucleic Acid Detection
WEST BRIDGEWATER, Mass., July 12 /PRNewswire/ -- Boston Biomedica, Inc. (Nasdaq: BBII) today announced that it has been issued a patent by the United States Patent and Trademark Office for the use of its proprietary Pressure Cycling Technology (PCT) for controlling the specificity of nucleic acid (DNA and RNA) hybridization ("binding"). "Pressure Controlled Nucleic Acid Hybridization" (US Patent No. 6,258,534) describes the use of high pressure to control nucleic acid hybridization, the process that forms the current basis of molecular identification and detection procedures (e.g., genomics). An important component of these claims is the ability of PCT to provide an alternative approach to current technologies used to control hybridization steps in nucleic acid amplification reactions, such as the polymerase chain reaction (PCR), for the detection of low levels of nucleic acids in a sample. Hybridization and amplification methods are routinely used by clinical, diagnostics, pharmaceutical, public health, forensic, agriculture, research, and other laboratories worldwide in their studies of infectious diseases, cancer, drug discovery, and other important areas.
Nucleic acid hybridization is the binding of two strands of DNA to each other in a zipper fashion, but only when a perfect or near-perfect complementary match of the two strands is present. This binding event makes possible the exquisite specificity needed for gene identification and diagnosis, the basis of the fields of DNA diagnostics and genomics. The current invention is based on the observation that high levels of pressure tend to stabilize perfect and near-perfect matches, thus allowing increased accuracy without sacrificing sensitivity. Furthermore, high pressure accelerates hybridization rates, potentially resulting in shorter binding times and more rapid data collection.
"The PCT enhanced hybridization can be carried out in an optical cell in which temperature and pressure are controlled for the rapid read-out of hybridization results," said Dr. Mark Manak, Senior Vice President of R&D at Boston Biomedica. "This approach may be particularly well suited for detection of small changes in DNA sequences, such as those arising from mutations. The technology may also be applicable to various screening applications, including new state-of-the-art bio-chip and array methods, in which the DNA from a single specimen can be simultaneously studied for numerous indications."
A particularly significant consequence of the increased control of hybridization with PCT is the potential to incorporate these features into techniques used for the amplification of nucleic acids. The most common method used worldwide for the amplification of relatively small amounts of DNA or RNA is the polymerase chain reaction (PCR), which relies on temperature cycling to repetitively hybridize and denature the two strands of DNA as the key part of the amplification reaction. Pressure Cycling Technology may provide an advantageous alternative or supplement to the temperature cycling steps of PCR, since pressure is transmitted more rapidly and uniformly than temperature through any reaction, resulting in efficient hybridization and separation of the DNA strands. Consequently, the PCT approach may result in more rapid amplification than current techniques, even for larger sample volumes, while further enhancing the accuracy required in the reaction.
"Although much work on the use of PCT in nucleic acid amplification still remains to be done, this patent describes a novel approach to amplification technology with many desirable features," said Richard T. Schumacher, Founder, CEO, and Chairman of Boston Biomedica. "This most recently issued patent is an important addition to our PCT intellectual property portfolio, and combined with the other five PCT patents already issued to BBI, should provide us with excellent patent protection over a broad range of innovative technologies to meet the growing needs of the diagnostics, genomics, research and therapeutic markets."
This is the sixth patent issued to BBI for the use of PCT. Previously issued patents include claims covering the instrumentation designed to carry out the PCT process, technology for lysing (breaking open) cells and tissues by exposure to alternating pressure pulses in order to release nucleic acids or proteins for analysis, modular devices for the separation and purification of nucleic acids, methods for purifying biological compounds based upon their differential binding to an immobile support at specified pressures, and nucleic acid sequencing.
Boston Biomedica, Inc. provides products and services for the detection and monitoring of infectious diseases such as AIDS and Viral Hepatitis. BBI has three operating 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 Biotech Research Laboratories, a research and development center providing R&D support for the other BBI business units, as well as contract research and repository services for the government, industry and other third parties, and (3) BBI Source Scientific, an ISO 9001 certified manufacturer of diagnostic instrumentation and medical devices. In addition, BBI is conducting research and development in Pressure Cycling Technology (PCT) through its subsidiary BBI BioSeq, with the goal of introducing new solutions for a number of important healthcare issues, including: inactivation of pathogens in human plasma, extraction of nucleic acids, food safety, and genomics. BBI also maintains a passive investment in Panacos Pharmaceuticals, a privately held antiviral drug and vaccine development company recently spun-off from BBI, whose goal is to introduce new solutions for the 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, including those in the area of nucleic acid hybridization and amplification; that pressure cycling technology may not be adaptable to any other commercially viable applications; that certain pressure cycling applications may not fall within the claims of the Company's six issued patents; and that individuals and groups utilizing such PCT procedures may not be required to license such technology from BBI. 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 Annual Report on Form 10-K (as amended) for the year ended December 31, 2000, Form 8-K filed March 8, 2001, Form 10-Q for the quarter ended March 31, 2001, and in the Company's Registration Statements on Form S-3 (Reg. No. 333-46426 and Reg. No. 333- 94379). Copies of these documents may be obtained by contacting the Company or the SEC.
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SOURCE Boston Biomedica, Inc.
Web site: http: //www.bbii.com
CONTACT: Richard T. Schumacher, CEO & Chairman, or Kevin W. Quinlan, President & COO, of Boston Biomedica, Inc., 508-580-1900
