WEST BRIDGEWATER, Mass., Sept. 11 /PRNewswire/ -- Boston Biomedica, Inc. (Nasdaq: BBII) announced today that five of the company's Accurun(TM) quality control products have been cleared for in vitro diagnostics (IVD) use by the U.S. Food and Drug Administration (FDA), bringing to fifteen the total of Accurun products cleared for such use.
Boston Biomedica, Inc., is a manufacturer and worldwide provider of proprietary quality control products for use with IVD test kits for the detection, analysis and monitoring of infectious diseases, including AIDS, Hepatitis and Lyme Disease. The company's Accurun product line is 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.
"Our Accurun product line is strong and growing," said Richard T. Schumacher, President and CEO of Boston Biomedica, Inc. "With 15 products cleared, four pending at FDA, and five to be submitted in the fourth quarter, we are moving rapidly toward our goal of offering the broadest range of commercially available, FDA-cleared quality control products for infectious disease. In addition, in 1997 we have developed and released for research use nine more products in the Accurun line."
Boston Biomedica, Inc. is comprised of the parent company in West Bridgewater and three wholly-owned subsidiaries; BBI-Biotech Research Laboratories in Rockville, MD, BBI Clinical Laboratories in New Britain, CT, and BBI-Source Scientific in Garden Grove, CA. In addition to its leadership role in quality control products, the company manufactures IVD test kit components and clinical laboratory instruments for diagnostics manufacturers and clinical laboratories throughout the world, and provides specialty laboratory testing services to a broad customer base of physicians and hospitals.
This release may include forward-looking statements that may or may not materialize. Additional information or factors that could potentially affect the Company's financial results may be found in the Company's filings with the Securities and Exchange Commission.
Factors which might cause actual results to differ materially from those
projected in the forward looking statements contained herein include the
following: inability of the Company to develop the end-user market for quality
control products; inability of the Company to integrate the business of Source
Scientific, Inc. into the Company's business; inability of the Company to
obtain an adequate supply of raw materials necessary for certain of its
products; significant reductions in purchases by any of the Company's major
customers; and the potential insufficiency of Company resources, including
human resources, plant and equipment and management systems, to accommodate
any future growth. Furthermore, there can be no assurance that the Company
will obtain regulatory clearances or approval on a timely basis, if at all,
for its products, changes in existing products or changes in claims relating
to uses of products. These and certain other factors which might cause actual
results to differ materially from those projected are more fully set forth
under the caption "Risk Factors" in the Company's Registration Statement on
Form S-1 (SEC File No. 333-10759).
SOURCE Boston Biomedica, Inc.
CONTACT: Richard T. Schumacher, President and CEO, or Kevin W. Quinlan, Chief Financial Officer of Boston Biomedica, Inc., 508-580-1900
