MILFORD, Mass.--(BUSINESS WIRE)--SeraCare Life Sciences, Inc. (NASDAQ: SRLS - News) today announced that the Company has developed a new series of controls in its ACCURUN portfolio to monitor and validate molecular diagnostic test performance for detection of Chlamydia trachomatis and Neisseria gonorrhoeae (CT/NG). Through collaboration with instrument and reagent manufacturers, SeraCare has optimized the ACCURUN 341 Nucleic Acid Positive controls specifically for use with the three most popular assays currently on the market; the Gen-Probe APTIMA Combo 2® Assay, the Roche COBAS® AMPLICOR CT/NG Test, and the Becton, Dickinson BD ProbeTec™ ET System.
“SeraCare has again set itself apart from other controls suppliers by offering whole cell, independent controls that challenge test kit reagents, analyzers and test procedures to achieve high quality standards,” said Susan Vogt, President and CEO of SeraCare. “The use of assay specific controls ensures optimal diagnostic performance. In addition, the controls for the Gen-Probe and BD assays are packaged in platform-compatible vials which can be placed directly on the manufacturers’ automated test platforms, minimizing processing time and the risk of adventitious contamination. We believe this suite of controls offers clinical diagnostic laboratories the means to ensure high quality and achieve new standards in testing for sexually transmitted infections.”
The ACCURUN 341 Nucleic Acid Positive controls for CT/NG are derived from cultured Chlamydia trachomatis and Neisseria gonorrhoeae and closely simulate an actual patient sample, challenging every stage of the assay from sample extraction through amplification and detection. ACCURUN controls are rigorously tested and manufactured in ISO 9001 and 13485 certified facilities. SeraCare’s complete catalog of diagnostic controls, plasma-derived reagents and molecular biomarkers is available online at www.seracarecatalog.com.
About SeraCare Life Sciences, Inc.:
SeraCare serves the global life sciences industry by providing vital products and services to facilitate the discovery, development and production of human diagnostics and therapeutics. The Company’s innovative portfolio includes diagnostic controls, plasma-derived reagents and molecular biomarkers, biobanking and contract research services. SeraCare’s quality systems, scientific expertise and state-of-the-art facilities support its customers in meeting the stringent requirements of the highly regulated life sciences industry.
Forward-Looking Statements:
This press release contains disclosures that are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 about SeraCare Life Sciences, Inc. (“SeraCare” or the “Company”). All statements regarding our expected future financial position, results of operations, cash flows, dividends, financing plans, business strategy, budget, projected costs or cost savings, capital expenditures, competitive positions, growth opportunities for existing products or products under development, plans and objectives of management for future operations and markets for stock are forward-looking statements. In addition, forward-looking statements include statements in which we use words such as “expect,” “believe,” “anticipate,” “intend,” or similar expressions. Although we believe the expectations reflected in such forward-looking statements are based on reasonable assumptions, we cannot assure you that these expectations will prove to have been correct, and actual results may differ materially from those reflected in the forward-looking statements. Factors that could cause our actual results to differ from the expectations reflected in the forward-looking statements in this press release include, but are not limited to, failure to maintain proper inventory levels, availability of financing, reductions or terminations of government or other contracts, interruption in our supply of products or raw materials, actions of SeraCare’s competitors and changes in the regulatory environment. Many of these factors are beyond our ability to control or predict.
Contact:
SeraCare Life Sciences, Inc. Gregory A. Gould, 508-244-6400 Chief Financial Officer or MacDougall Biomedical Communications Sarah Cavanaugh, 781-235-3060
