WEST BRIDGEWATER, Mass., Feb. 9 /PRNewswire/ -- Boston Biomedica, Inc. (Nasdaq: BBII) announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market Accurun 106 HIV Antigen Positive Control "For in-vitro diagnostic (IVD) use". This completes the Company's comprehensive series of controls used by blood banks in the U.S. and worldwide to help ensure quality results from the viral marker tests that are used to screen the blood supply.
Boston Biomedica, Inc. (BBI) is a manufacturer and provider of proprietary quality control products used with IVD test kits for the detection and monitoring of infectious diseases, including AIDS, Hepatitis, and Lyme Disease. In addition to blood banks, the Company's Accurun products are used by clinical and research laboratories, regulatory agencies, and IVD test kit manufacturers worldwide to help ensure the accuracy of test results through the routine monitoring of test kit performance.
"Our Accurun controls for blood bank testing remain one of our strongest and fastest growing product lines," commented Barry M. Warren, Senior Vice President and General Manager of BBI Diagnostics: the business unit responsible for the manufacture and sale of Accurun and the rest of the BBI quality control (TQS) product line. "Every year, approximately 26 million units of plasma and whole blood are screened for HIV antigen in the U.S. alone, and an FDA-cleared Accurun 106 provides our customers with an important, additional component of the quality control for this test."
"Boston Biomedica now supplies 31 FDA 510(k) cleared or exempt Accurun controls for the blood bank and other infectious disease markets, as well as an additional 19 'For research use only' Accurun controls", said Kevin W. Quinlan, President of BBI. "Our goal for this product line is to offer the broadest range of commercially available, FDA-cleared/exempt quality control products for infectious disease testing, and this latest clearance represents another step in that direction."
Boston Biomedica, Inc. is an infectious diseases management company providing products and services for the detection and treatment of infectious diseases 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 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 BBI may not be able to achieve the expected sales of Accurun 106. 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, 1998 and Quarterly Report on Form 10-Q for the quarters 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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SOURCE Boston Biomedica, Inc.
CONTACT: Richard T. Schumacher, CEO and Chairman, or Kevin W. Quinlan, President and COO, or William R. Prather, M.D., Sr. VP Finance & Business Dvlp., of Boston Biomedica, Inc., 508-580-1900, or fax, 508-580-1110
Web site: www.bbii.com
