Stratagene and Bayer HealthCare Enter Development and Supply Agreement for QPCR Instruments
March 14 2006 - 6:30AM
Business Wire
Stratagene Corporation (NASDAQ:STGN), a developer, manufacturer and
marketer of specialized life science research and diagnostics
products, announced today that Bayer HealthCare, Diagnostics
Division, a member of the Bayer Group (NYSE:BAY), will purchase
customized Mx3005P(TM) instrument systems for use in a new platform
Bayer is developing for performing molecular diagnostic tests
worldwide. Under the terms of the agreement, Stratagene will
develop customized software and system features for the Mx3005P
instrument for Bayer. Stratagene will receive milestone payments
based upon its completion of this customization and regulatory
activities needed to meet Bayer's clinical requirements. Bayer will
utilize Stratagene's Mx3005P instruments as components of its
modular quantitative Polymerase Chain Reaction (QPCR) systems which
will expand Bayer's product portfolio to address a broad customer
base in the in vitro diagnostic market. Stratagene's Cedar Creek
facility, where the Mx3005P systems will be manufactured for Bayer,
currently has ISO 13485 (International Organization for
Standardization) certification as a medical devices developer and
manufacturer. This certification indicates that Stratagene has
established and maintains an acceptable quality system with
management control to meet all applicable regulatory requirements.
"We chose to standardize on Stratagene's instrument technology
because the Mx3005P system offers a full-featured and reliable
platform that is small and economical," said Tom Warekois, Senior
Vice President of Global Strategic Marketing, Bayer HealthCare,
Diagnostics Division. "In addition, Stratagene has a reputation for
high-quality manufacturing and innovative design and we are
confident that it will be able to further develop the Mx3005P
system to meet our clinical needs." "This agreement with Bayer is a
very significant milestone for Stratagene," said Joseph A. Sorge,
MD, President and CEO of Stratagene. "Our long-term strategy is to
successfully create a full suite of products for the molecular
diagnostics marketplace. We believe that Bayer's decision to
partner with us validates our assertion that the Mx3005P system
offers a unique value proposition for the growing market."
Quantitative PCR is the most widely used technology for molecular
diagnostics testing, which is estimated to be a $1.5 billion
marketplace. Molecular testing has improved the process of
detecting the presence of agents that cause both viral and
non-viral infectious diseases. Using nucleic acid-based diagnostics
for the detection of DNA or RNA, clinical laboratories can deliver
results within hours, allowing patients to receive appropriate
treatment faster than with traditional testing methods. The greater
sensitivity of quantitative PCR testing methods allows for the
detection of microorganisms even when present in very low
concentrations. About Stratagene Corporation Stratagene is a
developer, manufacturer and marketer of specialized life science
research and diagnostic products. The Company's life science
research unit supports advances in science by inventing,
manufacturing and distributing products that simplify, accelerate
and improve research. These products are used throughout the
academic, industrial and government research sectors in fields
spanning molecular biology, genomics, proteomics, drug discovery
and toxicology. The Company's diagnostic unit develops and
manufactures products for urinalysis as well as high quality
automated instrument and reagent systems that use blood samples to
test for more than 1,000 different allergies and autoimmune
disorders. In addition, by combining its expertise in diagnostics
and molecular biology, as well as its experience with FDA
regulatory procedures, the Company is pursuing opportunities to
expand its product portfolio to include molecular diagnostic kits
and instrumentation. More information is available at
www.stratagene.com. About Bayer HealthCare, Diagnostics Division
Bayer HealthCare, Diagnostics Division, based in Tarrytown, New
York, U.S.A., is one of the world's market leaders in diagnostic
systems, with operations in more than 100 countries. The Company
offers an extensive portfolio of laboratory testing for urinalysis,
DCA (hemoglobin A1C), immunology, blood gas, hematology, molecular
and clinical chemistry testing to assess and manage health in a
myriad of disease states, including cardiovascular, kidney and
infectious diseases, oncology, and virology. The Company provides
diagnostic systems, laboratory automation and productivity
solutions and services to hospitals and health care systems,
laboratories and physician's offices across the world. Bayer
HealthCare Diagnostics Division operates as part of Bayer
HealthCare LLC, a member of the worldwide Bayer HealthCare group.
Safe Harbor Statement Certain statements in this news release that
are not historical fact constitute "forward-looking statements"
within the meaning of the Private Securities Litigation Reform Act
of 1995. Stockholders and other readers are cautioned not to place
undue reliance on these forward-looking statements. Stratagene
generally identifies forward-looking statements by using words like
"believe," "intend," "target," "expect," "estimate," "may,"
"should," "plan," "project," "contemplate," "anticipate," "predict"
or similar expressions. You can also identify forward-looking
statements by discussions of strategies, plans or intentions. Such
forward-looking statements involve known and unknown risks,
uncertainties and other factors, which may cause the actual results
of Stratagene to be materially different from historical results or
from any results expressed or implied by such forward-looking
statements. Among the important factors that could cause actual
results to differ materially from those contained in or implied by
the forward-looking statements are risks associated with the
company's inability to sufficiently anticipate market needs and
develop products and product enhancements that achieve market
acceptance, including molecular diagnostic testing kits and related
products, the company's ability to compete effectively in the
diagnostics and life sciences research markets, variability of the
company's quarterly revenues and operating results, the failure of
the company to retain key employees, the company's ability to
obtain additional debt or equity financing, the possibility of
declining sales due in part to a reduction in research and
development budgets or government funding, the company's ongoing
ability to protect its own intellectual property rights and to
avoid violating the intellectual property rights of third parties,
extended manufacturing difficulties and currency fluctuations. For
more information about these and other factors that could cause
actual results to differ materially from those contained in or
implied by the forward-looking statements please see "Factors that
May Affect Future Results" included in Stratagene's Annual Report
on Form 10-K for the year ended December 31, 2004 and in other
reports filed by Stratagene from time to time with the Securities
and Exchange Commission, including Quarterly Reports on Form 10-Q.
This news release contains forward-looking statements based on
current assumptions and forecasts made by Bayer Group management.
Various known and unknown risks, uncertainties and other factors
could lead to material differences between the actual future
results, financial situation, development or performance of the
company and the estimates given here. These factors include those
discussed in our public reports filed with the Frankfurt Stock
Exchange and with the U.S. Securities and Exchange Commission
(including our Form 20-F). The company assumes no liability
whatsoever to update these forward-looking statements or to conform
them to future events or developments.
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