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

Tue Jul 14, 2009 8:03am EDT
 
[-] Text [+]
-Only commercially available single-vial controls to cover all cystic fibrosis
mutations detected by leading testing platforms-
MILFORD, Mass.--(Business Wire)--
SeraCare Life Sciences, Inc. (NASDAQ: SRLS) 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 http://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 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 



Copyright Business Wire 2009

 

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