Virus Isolates To Be Provided By NIH, DOD and ENVA
WEST BRIDGEWATER, Mass., Feb. 3 /PRNewswire/ -- Boston Biomedica, Inc. (Nasdaq: BBII) announced today the signing of a Materials Transfer Agreement (MTA) with the National Institutes of Health (NIH), the Department of Defense (DOD), and the European Network for Virological Assessment of New HIV Therapies (ENVA) to transfer to BBI the title and possession of a unique collection of viral isolates representing multiple subtypes of HIV-1. This transfer will enable BBI to develop these isolates into much needed diagnostic products for the research community and commercial marketplace.
This collection consists of over 40 well characterized cultured isolates of HIV-1 representing the major virus subtypes occurring worldwide, including subtypes A,B,C,D,E,F,G,H & O. The contribution of these isolates is part of an international cooperative effort to make these rare and important materials available to researchers, regulatory agencies, diagnostics manufacturers and test kit users.
In the global AIDS epidemic, HIV-1 subtype B has been the predominant infectious agent in the U.S. and Europe, but the vast majority of HIV infections worldwide are not subtype B, but include a very high incidence of subtypes A, C and E, with other subtypes also found at increasing rates. Current HIV screening and quantitation tests have largely been validated with subtype B isolates; thus, other subtypes may not be accurately detected. The FDA has recently recommended that all new HIV assays be capable of detecting infection with each of the major subtypes of HIV, yet well characterized viral subtypes have been previously available only in very limited quantities or with extensive restrictions limiting their use. This MTA will allow Boston Biomedica, in cooperation with the contributors, to address the need for highly characterized, readily available new products for HIV test development and validation.
"We are very pleased that the international group of contributors recognized the need to release these reagents for more widespread commercial distribution, and have entrusted BBI with this subtype collection," said Kevin Quinlan, President of Boston Biomedica, Inc. "This comprehensive collection of HIV-1 subtypes will enable us to manufacture highly characterized virus panels for use in the development and evaluation of screening and diagnostic tests for HIV, and thus continue to significantly expand our quality control product line and markets."
"In the past, we have used standardized subtype B panels for the development of diagnostic tests to assure quality performance of HIV-1 testing in the USA and Europe," said Dr. James Bremer, Director of the Virus Quality Assurance Program sponsored by the NIH. "Now, with this expanded subtype panel, these same quality standards can be applied to the use of HIV-1 tests in developing countries, as well for the detection of emerging, non-B subtypes that may be present in the US."
Boston Biomedica, Inc. is an infectious diseases management company providing 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 wholly-owned subsidiary Panacos Pharmaceuticals), with the goal of introducing new solutions for the detection and treatment of infectious diseases.
Statements contained in this news release that describe 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 BBI may not be successful in culturing and characterizing sufficient quantities of the virus subtypes, or that these subtypes may not be useful in the validation of HIV assays. 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, 1998 and on Form 10-Q for the periods ended March 31, June 30, and September 30, 1999. 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. all of Boston Biomedica, Inc., 508-580-1900 (T), 508-580-1110 (F)
