WEST BRIDGEWATER, Mass., July 31 /PRNewswire-FirstCall/ -- Boston Biomedica, Inc. (Nasdaq: BBII) today announced that it has been awarded a Phase I Small Business Innovation Research (SBIR) Grant in the amount of $99,994 to demonstrate the feasibility of using its proprietary Pressure Cycling Technology (PCT), its Barocycler(TM) NEP2017 instrument, and its novel sample preparation device (PULSE(TM) Tube) to prepare sputum samples for diagnosis of tuberculosis. In particular, data from this study will provide the basis for development and commercialization of an automated system and disposable device for the collection and processing of sputum for improved detection of Mycobacterium tuberculosis (Mtb), the causative agent of tuberculosis.
Tuberculosis is one of the world's deadliest diseases. The World Health Organization (WHO) estimates that each year more than 8 million new cases of tuberculosis occur, and approximately 3 million people die from the disease. Current diagnosis of Mtb infection is based primarily on bacterial culture of sputum or other respiratory samples. Sample processing requires the release of bacteria from the sputum and treatment with decontaminating agents, such as harsh detergents, to inactivate the rapidly growing non-mycobacteria organisms present in these samples. Unfortunately, these treatments can also kill up to 90% of the target mycobacteria, significantly limiting the sensitivity and reliability of these methods. This grant proposes to develop a simplified device for collecting sputum samples and PCT processing to release the bacteria and preferentially inactivate the non-mycobacteria species. This device would simplify Mtb sample preparation, offer a safer closed system for handling specimens, and potentially increase sensitivity. These features would result in better patient management and an improved work environment for laboratory technicians.
"The processing of sputum and Mtb by Pressure Cycling Technology for clinical diagnosis is a logical extension of the work being done by Boston Biomedica in sample preparation," said Richard T. Schumacher, Founder, CEO, and Chairman of Boston Biomedica. "Commercialization efforts for our PCT Sample Preparation System led to the development of the Barocycler NEP2017 and PULSE Tubes. We are excited about the possibility of this particular application because of its potential to make a real difference in a difficult clinical diagnosis."
The PCT Sample Preparation System uses a BBI-designed and manufactured instrument, the Barocycler NEP2017, together with specially designed, multi- functional PULSE Tubes, to subject biological samples to repeated cycles of high and low pressures under controlled temperature ranges, to safely and effectively release nucleic acids and proteins from many types of cells and tissues. A major advantage of the PCT Sample Preparation System over other methods is that PCT conditions can be controlled to preserve the activity of released material, including intact DNA, RNA and biologically active proteins. A goal of this study is to determine whether the fine control that can be exerted by the PCT System can be used for preferential inactivation of normally occurring bacteria, while allowing the hardier bacteria, such as Mtb, to survive. The PCT System will also be used for effectively releasing the nucleic acid from these very resilient cells for use in molecular diagnosis.
"This grant will enable us to study the application of PCT for the clinical diagnosis of tuberculosis," said Dr. Mark Manak, Senior Vice President of R&D at BBI. "We are particularly pleased that we will be collaborating with Dr. Susan Dorman, M.D., from Johns Hopkins University and Dr. Steven Fischer, M.D., Ph.D., from the NIH in these studies. Both of these individuals are noted experts in the field, and their knowledge and expertise will be invaluable to us as we look at the potential applications of the PCT Sample Preparation System to the diagnosis of infectious disease."
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), with the goal of introducing new solutions for a number of important healthcare issues, including the extraction of nucleic acids and proteins, the inactivation of pathogens in human plasma, protein purification, food safety, and genomics. BBI also maintains a passive investment in Panacos Pharmaceuticals, a privately held antiviral drug and vaccine development company spun-off from BBI in 2000, 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 and protein sample preparation, as well as pathogen inactivation; that Pressure Cycling Technology may not be adaptable to any other commercially viable applications, including the clinical diagnosis of tuberculosis, detection of Mtb, or the release of whole viable Mtb organisms; that certain pressure cycling applications may not fall within the claims of the Company's eight 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 for the year ended December 31, 2001, and the Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2002. Copies of these documents may be obtained by contacting the Company or the SEC.
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SOURCE Boston Biomedica, Inc.
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CONTACT: Richard T. Schumacher, CEO & Chairman, or Kevin W. Quinlan, President & COO both of Boston Biomedica, Inc., +1-508-580-1900; or Jennifer Viera of Schneider & Associates, +1-617-536-3300, jviera@schneiderpr.com