and inactivation of viral pathogens prior to testing
WEST BRIDGEWATER, Mass., Aug. 11 /PRNewswire/ -- Boston Biomedica, Inc. (Nasdaq: BBII) announced today the signing of a Cooperative Research and Development Agreement with the National Institutes of Health Clinical Center (NIHCC) to develop applications of BBI's proprietary Pressure Cycling Technology (PCT) for clinical diagnostics procedures. This collaboration will primarily focus on three applications of PCT: (1) inactivation of pathogens in patient specimens prior to testing in the clinical lab, (2) extraction of nucleic acids from clinically relevant microorganisms that are particularly difficult to rupture, and (3) neutralization of antibodies that interfere with the accuracy of clinical assays. If successful, these PCT applications will increase laboratory worker safety and provide more rapid, sensitive, and accurate diagnosis, resulting in better patient care.
BBI has provided the NIH Clinical Center Laboratory with a BaroCycler(TM), the pressure cycling instrument that will be used in these collaborations, and has trained the staff in its operation. The BaroCycler, developed jointly by scientists at BBI BioSeq and engineers at BBI Source, two BBI business units, is capable of automatically cycling pressure between atmospheric levels and 50,000 pounds per square inch (psi), and at various temperatures and cycling times.
"We are very pleased to enter into this collaboration with a clinical laboratory so highly regarded for its extensive research and development capabilities," said Richard T. Schumacher, Founder, CEO, and Chairman of BBI. "We continue to remain extremely optimistic about the various potential applications of PCT, and are hopeful that this partnership will result in the generation of important new data that will help speed the development and commercialization of PCT, particularly as it relates to nucleic acid diagnostics and laboratory safety."
This collaboration is directed toward establishing and optimizing protocols that incorporate PCT into clinical specimen processing, and also to the development of instrumentation and sample containment suitable for routine applications of PCT in the clinical laboratory. The NIH will provide scientific expertise, staff, space in the clinical laboratory, and relevant clinical specimens to carry out the experimental protocols. The NIHCC and BBI will exchange data on a regular basis and will work closely to establish specifications for the design of a clinical laboratory instrument capable of rapidly processing large numbers of samples.
"Despite extensive precautions, laboratory-acquired infections continue to occur, and there is no completely satisfactory way to ensure the safety of clinical laboratory personnel," said Dr. Alan Remaley of the NIHCC, Principal Investigator of the virus inactivation studies. "Of particular concern are potential exposures to HIV and hepatitis viruses. Preliminary studies performed in our lab and at BBI have shown that the pressure cycling treatment required to inactivate certain viruses, such as HIV, had relatively little adverse effect on clinical chemistry results, including enzymes."
Commenting further, Dr. Steven Fischer of NIHCC, the Principal Investigator of the extraction studies, said, "In our laboratory, we will focus on using PCT to enhance existing tests for microorganisms. More effective methods are needed for nucleic acid (RNA & DNA) extraction from certain infectious agents, such as Mycobacterium and Microsporidia, which are difficult to rupture by conventional means because of the composition of their cell walls. PCT promises to provide a more effective means of breaking apart these organisms, and we have been quite encouraged by preliminary studies."
The third area of collaboration will examine the utility of PCT for eliminating interference factors sometimes present in the serum or plasma of patient specimens that can lead to inaccurate test results.
BBI 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 inactivation of pathogens and extraction of nucleic acids, other potential applications include the use of PCT in food safety, and for 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. Statements made by Dr. Remaley and Dr. Fischer in this press release do not constitute an endorsement of BBI or PCT by the NIH. 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 PCT into commercially viable products and services, that PCT may never become a better alternative than current methods for nucleic acid extraction, or that PCT may not be adaptable to any other commercially viable applications. 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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SOURCE Boston Biomedica, Inc.
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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
