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SeraCare, Inc. Expands Genetic Controls Product Portfolio with the Introduction of Cystic Fibrosis Controls

7/14/2009 6:51:31 AM

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MILFORD, Mass.--(BUSINESS WIRE)--SeraCare Life Sciences, Inc. (NASDAQ: SRLS - News) today announced that the Company has launched a new suite of products in its genetic controls portfolio to support cystic fibrosis genetic research. The controls, ACCURUN® 632, 644 and 676, are the only commercially available single-vial products that control for testing of all cystic fibrosis mutations detected by the leading testing platforms. Cystic fibrosis is a devastating hereditary chronic disease typically diagnosed in children before the age of two and is marked by mucus build-up and clogging of key organs in the body, especially the lungs and pancreas. A child must inherit two copies of the defective cystic fibrosis gene—one from each parent—to contract the disease. Approximately 30,000 children and adults are currently living with a diagnosis of cystic fibrosis in the United States and an additional ten million more—or about one in every 31 Americans—are carriers of the defective cystic fibrosis gene.

“The launch of SeraCare’s cystic fibrosis controls provides the market with a truly novel and differentiated suite of products now manufactured in a cGMP environment to more effectively support testing and research for one of the most commonly carried genetic disorders in the world,” said Susan Vogt, President and Chief Executive Officer of SeraCare. “These products raise the industry bar by providing researchers with a single-vial control that is able to challenge the accuracy of and detect errors for the industry’s leading cystic fibrosis genetic testing platforms, ultimately increasing efficiency and enabling researchers to run fewer controls and test more samples.”

About ACCURUN® 632, 644 and 676

ACCURUN® genetic quality controls for cystic fibrosis research provide an external measure of test accuracy enabling assay manufacturers and molecular research labs to meet regulatory requirements and ensure integrity of test results in an increasingly stringent regulatory environment. Manufactured with synthetic oligonucleotides, ACCURUN® 632, 644 and 676 expand SeraCare’s leadership and portfolio of quality controls in the genetic screening market. ACCURUN® 632 covers all mutations tested on the Abbott/Celera Cystic Fibrosis Genotyping Assay, ACCURUN® 644 covers all mutations testing on the Luminex xTag™ CFTR IVD Assay and ACCURUN® 676, when used in conjunction with ACCURUN® 644, covers all mutations tested by the Luminex xTag™ CFTR 70+6 Assay. These controls are manufactured and distributed under an exclusive licensing and technology transfer agreement with Sacred Heart Medical Center & Children’s Hospital, Spokane, WA, which allows SeraCare to manufacture and distribute these controls under patents and proprietary know-how owned by Sacred Heart, previously distributed under the Molecular Controls™ name. For more information about these and other ACCURUN control products, please visit

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 includes "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. All statements other than statements of historical facts included in this press release are forward-looking statements. All statements regarding SeraCare's expected future financial position, results of operations, cash flows, financial plans, business strategy, capital expenditures, plans and objectives of management for future operations, as well as statements that include words such as "anticipate," "if," "believe," "plan," "estimate," "expect," "intend," "may," "could," "should," "will," and other similar expressions are forward-looking statements. Such forward-looking statements are inherently uncertain, and readers must recognize that actual results may differ materially from SeraCare's expectations. Factors that may cause actual results to differ materially from those in the forward-looking statements include, but are not limited to, results of litigation, government investigations, the availability of financing, actions of SeraCare's competitors and changes in general economic conditions. Certain of the risks and factors associated with SeraCare's business are also discussed in the Company's 2007 Form 10-K and in other reports filed from time to time with the Securities and Exchange Commission. All these risks and factors should be taken into account in evaluating any forward-looking statements. Many of these factors are outside of SeraCare's control. SeraCare does not undertake a duty to update any forward-looking statements contained herein.


SeraCare Life Sciences, Inc. Gregory A. Gould, 508-244-6400 Chief Financial Officer or Investor Relations MacDougall Biomedical Communications Sarah Cavanaugh, 781-235-3060

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