Quantcast
Last updated on April 18, 2014 at 7:49 EDT

SeraCare Launches Genetic Testing Controls Business Line

October 30, 2008

SeraCare Life Sciences, Inc. (NASDAQ: SRLS) launched the Company’s anticipated genetic controls business with the introduction of two new products at the Association for Molecular Pathology 2008 Annual Meeting. Initial products launched include ACCURUN(R) 601 controls for diagnostic testing of warfarin sensitivity and ACCURUN(R) 610 controls for thrombophilia testing, which were developed internally by SeraCare. Additionally, the Company announced that it has entered into an exclusive licensing and technology transfer agreement with Sacred Heart Medical Center & Children’s Hospital, Spokane, WA, which allows SeraCare to manufacture and distribute additional controls for genetic testing, including screening for cystic fibrosis and for diseases common among people of Ashkenazi Jewish ancestry, under patents and proprietary know-how owned by Sacred Heart.

“SeraCare intends to build a thriving genetic controls business line offering differentiated genetic controls that make our customers’ jobs easier and more productive. We will apply the same in-house expertise, quality systems and state-of-the-art manufacturing facilities that are driving double-digit growth in our molecular controls business to our new genetic controls franchise,” said Susan Vogt, President and CEO. “In the coming months, we will continue to make key additions to the genetic controls product portfolio as this business line plays an important role in the Company’s near-term growth strategy and future profitability.”

About ACCURUN(R) 601:

Warfarin is the most widely prescribed oral anticoagulant for thrombosis, stroke and other clotting disorders. In August of 2007 the Food and Drug Administration approved a re-labeling of warfarin that indicates new patients on warfarin should undergo genetic testing prior to long term use of the drug to alleviate dosing regimen problems and reduce adverse events, including significant risk of bleeding. Two genes seem to have an effect on warfarin sensitivity: CYP2C9 and VKORC1. Developed with human donor genomic DNA, ACCURUN(R) 601 includes the most relevant alleles for warfarin sensitivity and is the only control kit in this market configured as a single package to control for both CYP2C9 and VKORC1 screening. Single package design will enable molecular testing labs to increase test throughput of patient samples, optimizing instrument capacity.

About ACCURUN(R) 610:

The genes associated with thrombophilia have been shown to cause pregnancy complications and infertility. Methylenetetrahydrofolate reductase (MTHFR) may represent an important genetic risk factor for thrombophilia. ACCURUN(R) 610 is a multi-analyte control for genetic screening of MTHFR that includes the most relevant alleles in a single package. Concurrent screening of MTHFR with Factor II and Factor V screening for thrombophilia offers clinicians a more complete picture of the genetic component of the thrombotic phenotype. By using ACCURUN(R) 610 multi-analyte controls, labs can increase test throughput of patient samples, optimizing instrument capacity.

About the Sacred Heart Medical Center Agreement:

The agreement with Sacred Heart Medical Center is an exclusive agreement for the manufacture and distribution of Sacred Heart’s multi-analyte synthetic controls for genetic testing for cystic fibrosis and for diseases associated with Ashkenazi Jewish ancestry by SeraCare Life Sciences. The patented method for design, synthesis and production of synthetic nucleic acid reference materials for use in multiplexed assays allows for consistent production in potentially unlimited quantities. These products will now be manufactured at SeraCare’s cGMP compliant and ISO 9001 and 13485 certified facilities and, once validated by individual laboratories, can result in a vastly improved and more efficient quality control program. The agreement also includes a license to manufacture and commercialize additional future products under the know-how and intellectual property owned and controlled by Sacred Heart.

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.

About Sacred Heart Medical Center & Children’s Hospital

Scientists at Sacred Heart’s molecular diagnostics department developed methods for the design and production of synthetic DNA molecules (U.S. Patent No. 7425413). Subsequent testing and validation showed that these synthetic controls can be used as references for research use in the detection of mutations in genetic screening assays. With 623 beds, Sacred Heart is one of the largest hospitals in the Pacific Northwest. It employs over 4,000 health care professionals and support staff. Its medical staff provides the expertise and skills of over 800 specialists and primary care doctors. In addition to a full-service Children’s Hospital, Sacred Heart features comprehensive cardiac programs, a certified Stroke Center, Level II Trauma Center and neuroscience, psychiatric, continence and cancer services. — www.shmc.org

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.