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Boston Biomedica Announces 510(K) Clearance For Lyme IgM Western Blot Kit
PR Newswire - March 25, 1999 16:55
WEST BRIDGEWATER, Mass., March 25 /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 its Borrelia burgdorferi IgM (Lyme IgM) Western Blot test kit. The test is used following a screening test as part of a two-step process for determination of recent exposure to B. burgdorferi, the causative agent of Lyme disease.
"BBI initially developed the Lyme IgM and its companion IgG Western blot tests at BBI Biotech Research Laboratories (BBI Biotech) for use at BBI Clinical Laboratories (BBICL). Our positive experience with these tests in our own laboratories led us to the decision to seek FDA clearance for commercial distribution," said Richard C. Tilton, Ph.D., Senior Vice President and Scientific Director, BBICL. "BBI Biotech has a long and distinguished history in development of diagnostic tests for infectious disease markers, and more recently for nucleic acids of clinical interest. Therefore, it is no surprise that we have found these Lyme disease tests superior to others we have evaluated."
"The continued success of both tests at BBICL, and the clearance of the Lyme IgM test for commercial distribution, demonstrate again the synergy that we have built among our business units," stated Richard T. Schumacher, President and CEO of BBI. "A test that has been developed and manufactured through our research and development group (BBI Biotech) for use at our clinical laboratories (BBICL) will now become available for OEM distribution from our diagnostics group (BBI Diagnostics). We are very pleased at having achieved a relatively expeditious clearance for the IgM Western Blot test, and are now preparing to submit to FDA the data for the companion Lyme IgG test kit."
BBI Biotech (Gaithersburg, Maryland) offers a variety of research services in molecular biology, cell biology and immunology to government agencies, diagnostic kit manufacturers and biomedical researchers. BBICL (New Britain, Connecticut) is a fully accredited specialty reference laboratory dedicated to the laboratory diagnosis of infectious diseases, and in addition is FDA registered for blood bank supplemental testing for HIV, HTLV and viral hepatitis.
Boston Biomedica Inc. is a worldwide manufacturer and provider of proprietary quality control products for use with IVD test kits for the detection, analysis and monitoring of infectious diseases, including AIDS, Hepatitis, Lyme Disease and ToRCH. The Company's products are used by clinical and research laboratories, blood banks, and IVD manufacturers to help ensure the accuracy of infectious disease test results through the routine monitoring of test performance. The Company also manufactures diagnostic test kit components and laboratory instrumentation, provides specialty laboratory testing and contract research services, and has significant R&D investment in pressure cycling technology (PCT) and anti-HIV drug discovery.
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 unforeseen technical, financial, marketing, and other difficulties, the Lyme disease test kits described may not ultimately be commercialized, or if commercialized, may not be financially successful for the Company, and the Lyme IgG test kit may not receive FDA 510(k) clearance. 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-Q for the period ended June 30, 1998. Copies of this document may be obtained by contacting the Company or the SEC.
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SOURCE Boston Biomedica, Inc.
/CONTACT: Richard T. Schumacher, President & CEO, or Kevin W. Quinlan,
Chief Financial Officer, or William R. Prather, MD, Sr. VP Business
Development of Boston Biomedica Inc., 508-580-1900/
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