WEST BRIDGEWATER, Mass., Aug. 28 /PRNewswire/ -- Boston Biomedica, Inc. (Nasdaq: BBII) announced today that BBI Clinical Laboratories of New Britain, CT (a wholly-owned subsidiary of Boston Biomedica) has launched a new antibody test for Lyme Disease called the C6 Lyme Peptide ELISA (VlsE). There is a nationwide market for Lyme Disease testing, but accurate diagnosis has been hampered to date by inadequate tests. The Company believes that this new test offers a significant breakthrough in accuracy. BBI Clinical Laboratories is the first reference laboratory to make this test commercially available.
The test for antibodies to a surface lipoprotein found in all strains of Borrelia burgdorferi was first reported late last year by Dr. S. J. Norris and coworkers at the University of Texas and by Dr. Mario Philipp and his group at Tulane University. This newly discovered protein, called VlsE, has the ability to change its structure, thus avoiding the patient's immune response. VlsE consists of both variable and invariable parts. One of these invariable parts, C6, produces a strong antibody response in patients with Lyme Disease, and is able to distinguish between patients with Lyme Disease and those who have been vaccinated to help prevent the disease. Many of the tests currently in use have a positive reaction as a result of the recently approved Lyme Disease vaccine, which has been given to thousands of people over the past year. This new test, the C6 Lyme Peptide ELISA(C6 LPE), has several features contributing to its accuracy and reproducibility in a wide range of patients. These include:
a. Accurate and reliable testing in those patients who have had the Lyme
Disease vaccine.
b. Ability to detect antibodies to all US and European strains of
B.burgdorferi.
c. High specificity for Lyme Disease. Patients with autoimmune diseases,
non-Lyme arthritis, syphilis, infectious mononucleosis, and lupus
erythematosis will not test positive with this C6 LPE.
d. Improved sensitivity in all stages of Lyme Disease including those
patients with late stage disease.
"We are very pleased to announce the availability of this new test for Lyme Disease. It is the first commercially available test that can be used in vaccinated patients. Because the test is so specific, there will be fewer false positive results than we currently see," commented Dr. Richard C. Tilton, Senior Vice President for Science and Technology at BBI Clinical Laboratories and an internationally recognized expert on testing for tickborne infections. "BBI Clinical Laboratories has worked very closely with Immunetics, Inc., Cambridge, MA, the developer of the C6LPE test kit, to make this test available."
Ms. Karen Forschner of the Hartford-based Lyme Disease Foundation said, "We are very excited that this test has the potential to identify missed cases of Lyme Disease as well as to detect both early and late disease."
Lyme Disease continues to be the most prevalent tick-borne disease in the U.S. As of August 2000, there have been over 145,000 cases of Lyme Disease reported to the CDC since 1980. Annual incidence of the disease since 1996 is over 15,000 cases per year. Lyme Disease is under-reported and the true incidence may be 10 times the reported incidence.
In addition to the new VlsE, BBI Clinical Laboratories offers a comprehensive range of carefully validated tests for tickborne pathogens, including confirmatory tests for Lyme Disease, and tests for human ehrlichiosis and another tickborne pathogen, Babesia microti.
BBI Clinical Laboratories specializes in testing for a broad range of infectious diseases including AIDS, Hepatitis, and tick borne diseases, utilizing immunology, microbiology, and molecular diagnostic based test formats. Its services are offered to physicians, hospitals, clinics, and other reference laboratories.
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. Factors that could cause actual results to differ from those projected include the possibility the new C6 Lyme Peptide ELISA (VlsE) test may not become either widely utilized or a commercial success. 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 periods ended March 31 and June 30, 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 & Chairman, or Kevin W. Quinlan, President & COO, or William R. Prather, M.D., Sr. VP Finance & Business Dvlp., of Boston Biomedica, Inc., 508-580-1900