WEST BRIDGEWATER, Mass., Feb. 27 /PRNewswire-FirstCall/ -- Boston Biomedica, Inc. (Nasdaq: BBII) today announced that seven of its Accurun 1(R) Positive Control products designed for the European market have been 'approved to CE Mark' by G-Med, a designated Notified Body under the European Union's In Vitro Diagnostics Directive. The IVD Directive describes criteria that must be met and steps that must be taken for IVD products to be qualified for sale in European Union countries beginning at the end of 2003.
In the IVD Directive, the European Union classifies products according to the risks associated with their failure or misuse, and establishes a process leading to a CE Mark (approval to sell a product in EU countries) for each category. BBI's Accurun 1 product line is in the highest risk category because these products are intended for use with tests for HIV and Hepatitis B and C; thus the criteria for approval to CE Mark are the most stringent, and require Notified Body review.
"Our staff, under the direction of Debbie Petit, Senior Manager of Regulatory Affairs for BBI Diagnostics and Project Leader for the CE Marking Team, has gained valuable experience in reaching this goal of approval to CE Mark for the Accurun 1 product line," said John Swatosh, Director, Sales and Marketing for BBI Diagnostics. "We chose to clear the highest hurdle first, because Accurun 1 is our biggest-selling quality control product.
"Approval to CE Mark for Accurun 1 products is another important step in support of our TQS sales in European Union countries," said Kevin Quinlan, President & Chief Operating Officer of Boston Biomedica, Inc. "Together with the ISO13485 Certification, this approval sends a clear message to our international distribution network that they can count on BBI to work with them for approval of our products within their regulatory systems, and demonstrates our commitment to attain the highest quality standards in existence throughout the world."
Boston Biomedica, Inc. provides products and services to the diagnostics and life sciences industries 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. We also manufacture biological reagents used in test kits, and provide a broad range of routine and esoteric research services to governments and industry. BBI has facilities in three states, and conducts research in new applications for our patented Pressure Cycling Technology (PCT). In 2000, we launched Panacos Pharmaceuticals, and the Company maintains a significant passive investment in this novel antiviral drug development company.
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 the Company may not be successful in satisfying the applicable regulatory standards for approval of the Company's other QC products, the Company may not receive CE marking for any of its other QC products, or that such CE marking may take longer than expected. In addition, there is no guarantee that achieving CE marking will increase sales in international markets. 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 Annual Report on Form 10-K for the year ended December 31, 2001, the Company's quarterly reports on Form 10-Q for the three months ended March 31, June 30, and September 30, 2002 and under the caption "Risk Factors" in the Company's Registration Statements on Form S-3 (SEC File Nos. 333-94379 and 333-46426). Copies of these documents may be obtained by contacting the Company or the SEC.
Visit us at our website http://www.bbii.com
Please email us at IR@bbii.com if you prefer to receive future announcements electronically
Investor Contacts:
Kevin W. Quinlan, President& COO
Boston Biomedica, Inc.
508-580-1900 (T)
SOURCE Boston Biomedica, Inc.