Phase I Grant will fund a collaborative program
with the University of Maryland for the development
of diagnostic reagents and test systems for "Mad Cow" disease
WEST BRIDGEWATER, Mass., April 17 /PRNewswire-FirstCall/ -- Boston Biomedica, Inc. (Nasdaq: BBII) today announced that it has been awarded a Phase I Small Business Technology Transfer Grant (STTR) to develop a highly sensitive assay for the detection of prion proteins in blood. This collaborative study with the University of Maryland proposes to apply the exquisite sensitivity of nucleic acid amplification technologies to the detection of very low levels of infectious prions in blood. The first year funding of $123,000 for the project will support the development of detection reagents and amplification systems that, if successful, can subsequently be included in a Phase II grant request to assemble and validate the test for use in blood and other biological specimens.
Prion diseases, which include new variant Creutzfeld Jakob Disease (nvCJD), are Transmissible Spongiform Encephalopathies (TSE), infectious diseases with long incubation periods and 100% fatality rates. These diseases cannot yet be diagnosed prior to the occurrence of symptoms. Probably the best known example of TSE is "Mad Cow" disease, which has been shown to infect humans through infected beef. Recent outbreaks in the United Kingdom and elsewhere have led to extensive testing of European cattle destined for the food supply. Although no direct evidence for blood transmission in humans currently exists, the theoretical possibility of such transmission has spurred the FDA to establish programs to screen out potential donors at risk for nvCJD. In addition, there is a public health need for a screening test that can both help to protect the blood supply and screen live animals to ensure food safety. Current assays for TSE target detection of prions in the brains of infected cattle, and are suitable only for detection of late stage disease, where large amounts of prion proteins have accumulated. No test currently exists for early stage disease or for screening of live animals or humans.
"In this grant, we propose to develop a highly specific antigen capture method for prion proteins coupled to a nucleic acid based probe. This approach applies the power of the nucleic acid amplification methods to the detection of very low levels of prion proteins in blood and other tissues," said Dr. Mark Manak, Senior Vice President of Research and Development at BBI. "We are particularly pleased to be working on this project with Dr. Neil Constantine and a very distinguished group of scientists at the University of Maryland School of Medicine, who have extensive expertise in the development of diagnostic assays. Our initial collaboration with this team has generated very encouraging preliminary results."
"BBI's strong background in infectious diseases is well recognized, and we are looking forward to expanding our capabilities to include this very challenging and economically important agent," said Richard T. Schumacher, Founder, Chairman and CEO of Boston Biomedica. "This work will also tie in very well to our goal of developing rapid, efficient, and safe sample preparation methods using our patented Pressure Cycling Technology (PCT), especially for processing difficult and potentially dangerous samples such as brain tissue."
Neil Constantine, Ph.D., Professor in the Department of Pathology and Director of the Clinical Immunology Laboratory at the University of Maryland School of Medicine, said: "We are pleased to be joining forces with Boston Biomedica, where numerous innovative tests have not only been developed over the years, but have also been successfully used in clinical laboratories. This collaboration will increase the likelihood that a successful research and development effort will lead to rapid commercialization of a test, which is the ultimate goal of both BBI and the University of Maryland researchers, as well as of the NIH STTR program."
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 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 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 commercially viable prion detection products, BBI's patented Pressure Cycling Technology (PCT) may not be required in the sample preparation for such product or service, or that individuals and groups utilizing such reagents and 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 Quarterly Reports on Form 10-Q for the three months ended March 31, June 30, and September 30, 2001, and Current Report on Form 8-K filed March 8, 2001. Copies of these documents may be obtained by contacting the Company or the SEC.
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Investor Contacts: Media Contact:
Richard T. Schumacher, CEO & Chairman Jennifer Viera
Kevin W. Quinlan, President & COO Schneider & Associates
Boston Biomedica, Inc. 617-536-3300 (T)
508-580-1900 (T) jviera@schneiderpr.com
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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, both of Boston Biomedica, Inc., +1-508-580-1900; or Jennifer Viera of Schneider & Associates, +1-617-536-3300, jviera@schneiderpr.com