WEST BRIDGEWATER, Mass., Jan. 21 /PRNewswire/ -- Boston Biomedica, Inc. (Nasdaq: BBII) announced today that an additional four of the company's Accurun(TM) quality control products have been cleared for in vitro diagnostic (IVD) use by the U.S. Food and Drug Administration (FDA). Two of these products are multi-analyte controls for blood bank viral marker screening; the other two are single analyte controls for ToRCH testing. ToRCH is an acronym for a group of infections that can have particularly deleterious effects if contracted during pregnancy: Toxoplasmosis, Rubella, Cytomegalovirus (CMV) and Herpes.
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 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 goal for the Accurun product line is to offer the broadest range of commercially available, FDA-cleared, quality control products for infectious disease testing, and these clearances represent still another step in that direction," said Richard T. Schumacher, President and CEO of Boston Biomedica, Inc. "We now have 19 cleared products, six pending at the FDA, and another 12 available for research use".
In addition, in response to customer requests, BBI last month introduced their first software product in support of Accurun controls. "AccuChart(TM) allows laboratories to monitor their Accurun control results with elegant, user-friendly charts and graphs," said Barry M. Warren, Sr. VP of Sales and Marketing. "In both the breadth of our product lines and in our attention to customer needs, BBI is stronger than ever".
This release may include forward-looking statements that may or may not materialize. Additional information or factors that could potentially affect BBI'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
renew all of the existing field service contracts recently assigned to BBI-
Source Scientific; uncertainty of research contract renewals; inability of
BioSeq to develop its technology to the level of commercial utilization;
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. 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
