WEST BRIDGEWATER, Mass., Dec. 5 /PRNewswire-FirstCall/ -- Boston Biomedica, Inc. today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its BBI Borrelia burgdorferi IgM and IgG Western Blot Test Kit. The test method separately detects IgM and IgG antibodies to B. burgdorferi, the infectious tickborne bacteria that cause Lyme Disease. The FDA's 510(k) clearance allows the test to be marketed and sold in the U.S. with the label 'For In Vitro Diagnostic Use'.
The BBI Borrelia burgdorferi IgM and IgG Western Blot Test Kit is intended for use in testing human serum samples that have been found positive or equivocal using a first-line test (enzyme immunoassay or immunofluorescence assay) for B. burgdorferi antibodies. The Western blot method identifies specific antibodies, and according to CDC guidelines, a supplementary test such as the Western blot should be used to provide additional information following a positive or equivocal result with the first-line Lyme test.
"This is the same test we developed and manufactured at our BBI Biotech Research Lab in the mid-1990s for use in our clinical laboratory," commented Dr. Patricia E. Garrett, BBI's Senior Vice President for Science and Technology. "When the clinical laboratory was sold, and our market research indicated a need for a high quality Western blot, we applied to the FDA for clearance using information we had collected in earlier clinical trials."
Kevin Quinlan, President and COO of BBI, said "We had several years of experience manufacturing and using this test in our own laboratory, and are pleased to be able to market it for in vitro diagnostic use. The market for the Lyme Western blot test includes hospital and clinical reference laboratories that our Accurun salespeople currently call on, so we have very cost-effectively added a product for this market."
About Boston Biomedica, Inc.
BBI provides products and services to the diagnostics and life sciences industry to evaluate, monitor, and ensure the quality of infectious disease test results, to improve the preparation of specimens for genomic/proteomic testing, and to safely store and retrieve rare and valuable biological specimens. The Company also manufactures reagents used in test kits and provides a broad range of routine and esoteric research services to governments and industry. BBI operates in three states, and conducts research in new applications for our patented Pressure Cycling Technology (PCT). In 2000, the Company launched Panacos Pharmaceuticals and maintains a significant passive investment in this novel antiviral drug development company.
Forward Looking Statements
Statements contained in this news release regarding 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 commercializing the BBI Borrelia burgdorferi IgM and IgG Western Blot Test Kit, or that such activities may take longer, or may require more financial, technical, and marketing resources than currently expected. Additional information concerning factors that could cause actual results to differ materially from those in the forward-looking statements, and risk factors, is contained in the Company's recent filings with the Securities and Exchange Commission of its Annual Report on Form 10-K for the year ended December 31, 2002, and on Form 10-Q's for the quarters ended March 31, June 30, and September 30, 2003. Copies of these documents may be obtained by contacting the Company or the SEC. Copies of these documents may be obtained by contacting the Company or on the SEC's website located at http://www.sec.gov/.
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Investor Contact:
Kevin W. Quinlan, President & COO
Boston Biomedica, Inc.
(508) 580-1900 (T)
(508) 580-1110 (F)
Boston Biomedica, Inc.