QIAGEN and Abbott Enter Into Agreement on Molecular Tests for HIV, HCV and HPVBy Qiagen, PRNE
Monday, October 11, 2010
Agreement Significantly Adds to the North American Test Menus of Both Parties and Aims to Increase the Adoption of HPV Screening
GERMANTOWN, Maryland and DES PLAINES, Illinois, October 12, 2010 - QIAGEN (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) and
Abbott (ABT: NYSE) today announced that they have entered into an agreement
that significantly strengthens both companies' testing menus for automated
in-vitro diagnostic applications in the United States and Canada. Financial
terms were not disclosed.
Under the terms of the agreements, QIAGEN will receive kits
for a PCR-based molecular assay for HIV-1 viral load testing in the U.S. and
Canada which will be commercialized under QIAGEN's brand. This test will
enable healthcare professionals to measure the viral load of HIV infections
in patients. It is expected that the new HIV-1 test will be available by
2012, thereby adding to QIAGEN's pipeline of U.S. regulatory submissions
which is expected to also include a quantitative HBV (Hepatitis B) test. In
addition, Abbott will provide a quantitative HCV (Hepatitis C) test which
will be optimized and labeled for use on QIAGEN's QIAsymphony RGQ instrument
and marketed under the Abbott brand in the U.S. and Canada. Subject to
regulatory approval, this test may be available by the end of 2012.
QIAGEN will supply Abbott with certain key products required
for a PCR-based HPV (human papillomavirus) test in the U.S. and Canada. This
test will run on Abbott's m2000 lab automation system which features
throughput up to 96 samples per run. QIAGEN itself will continue to address
the HPV screening market with its prevention platform QIAensemble which is
designed to process up to 2,000 samples per shift. Technologies which are the
basis of QIAGEN's current and next-generation HPV screening assays are not
subject to the transaction.
Tests for HIV and HCV are currently among the most widely used
commercial applications in molecular diagnostics, with U.S. markets estimated
to be in the range of US$ 180 and 140 million in annual sales, respectively.
Laboratories with molecular diagnostic capabilities usually include these
frequently performed assays in their testing menus. QIAGEN and Abbott believe
that these agreements significantly strengthen the value of their respective
automation platforms and will reinforce their leadership in infectious
disease testing. QIAGEN's QIAsymphony RGQ system was launched last month with
a broad portfolio of assays, including HIV, HBV and HCV tests, and is
registered for clinical use in European markets.
"The agreement is a good strategic fit," said QIAGEN's CEO
Peer Schatz. "It has the potential to significantly accelerate our
dissemination strategy for the QIAsymphony RGQ by expanding our molecular
diagnostic menu offering in the United States with important testing options.
It also allows us to commercialize previously unused intellectual property
around a PCR design for HPV assays by converting it into revenue and by
targeting it into a clearly defined sub-segment of the market. And, finally,
it enables both parties to address the different market segments for HPV and
thereby promises to further drive market adoption of this important testing
method in North America."
"We're pleased to provide QIAGEN access to our leading
technology, and believe the addition of a PCR-based HPV test to our m2000
menu will benefit many more women who may be infected with the virus and at
risk of developing cervical cancer," said Stafford O'Kelly, head of Abbott's
molecular diagnostics business.
QIAGEN's portfolio already includes a broad menu of assays
including FDA approved assays for HPV (digene HPV) and chlamydia as well as
CE-labeled tests for the detection of HIV, HCV, hepatitis B virus (HBV),
cytomegalovirus (CMV), Epstein-Barr virus (EBV), herpes-simplex virus (HSV),
Influenza, multiple bacteria and respiratory viruses, personalized healthcare
assays such as KRAS, EGFR, as well as many other target diseases. In
addition, QIAGEN has a broad pipeline of additional and novel assays for its
QIAsymphony and QIAensemble platforms for launch in the U.S., Europe and in
many other countries in 2011 through 2013.
Abbott offers a broad menu of tests on its m2000 system
outside the United States including tests for HIV viral load, hepatitis B and
C viral load, hepatitis C genotyping, chlamydia, gonorrhea, human
papillomavirus, cytomegalovirus, Epstein-Barr virus, and methylated septin 9
(mS9) for colorectal cancer. Tests approved in the United States include
those for HIV, HBV, chlamydia and gonorrhea.
QIAGEN N.V., a Netherlands holding company, is the leading
global provider of sample and assay technologies. Sample technologies are
used to isolate and process DNA, RNA and proteins from biological samples
such as blood or tissue. Assay technologies are used to make such isolated
bio-molecules visible. QIAGEN has developed and markets more than 500 sample
and assay products as well as automated solutions for such consumables. The
company provides its products to molecular diagnostics laboratories, academic
researchers, pharmaceutical and biotechnology companies, and applied testing
customers for purposes such as forensics, animal or food testing and
pharmaceutical process control. QIAGEN's assay technologies include one of
the broadest panels of molecular diagnostic tests available worldwide. This
panel includes the digene HPV Test, which is regarded as a "gold standard" in
testing for high-risk types of human papillomavirus (HPV), the primary cause
of cervical cancer, as well as a broad suite of solutions for infectious
disease testing and companion diagnostics. QIAGEN employs more than 3,500
people in over 30 locations worldwide. Further information about QIAGEN can
be found at www.qiagen.com/.
Abbott is a global, broad-based health care company devoted to
the discovery, development, manufacture and marketing of pharmaceuticals and
medical products, including nutritionals, devices and diagnostics. The
company employs nearly 90,000 people and markets its products in more than
130 countries. Abbott's news releases and other information are available on
the company's Web site at www.abbott.com.
QIAGEN Safe Harbour Statement
Certain of the statements contained in this news release may
be considered forward-looking statements within the meaning of Section 27A of
the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S.
Securities Exchange Act of 1934, as amended. To the extent that any of the
statements contained herein relating to QIAGEN's products, markets, strategy
or operating results are forward-looking, such statements are based on
current expectations that involve a number of uncertainties and risks. Such
uncertainties and risks include, but are not limited to, risks associated
with management of growth and international operations (including the effects
of currency fluctuations and risks of dependency on logistics), variability
of operating results, the commercial development of the applied testing
markets, clinical research markets and proteomics markets, nucleic acid-based
molecular diagnostics market, and genetic vaccination and gene therapy
markets, competition, rapid or unexpected changes in technologies,
fluctuations in demand for QIAGEN's, products (including fluctuations due to
the level and timing of customers' funding, budgets, and other factors), our
ability to obtain regulatory approval of our infectious disease panels,
difficulties in successfully adapting QIAGEN's products to integrated
solutions and producing such products, the ability of QIAGEN to identify and
develop new products and to differentiate its products from competitors'
products, market acceptance of QIAGEN's new products and the integration of
acquired technologies and businesses. For further information, refer to the
discussions in reports that QIAGEN has filed with, or furnished to, the U.S.
Securities and Exchange Commission (SEC).
Investor Relations: Dr. Solveigh Mahler Director Investor Relations QIAGEN +49-2103-29-11710 e-mail: firstname.lastname@example.org Albert F. Fleury Investor Relations North America QIAGEN +1-301-944-7028 e-mail: email@example.com Angela Duff Abbott Investor Relations +1-847-938-6894 firstname.lastname@example.org Public Relations: Dr. Thomas Theuringer Director Public Relations QIAGEN +49-2103-29-11826 e-mail: email@example.com Don Braakman Abbott Public Affairs +1-847-937-0080 Don.Braakman@abbott.com
Investor Relations: Dr. Solveigh Mahler, Director Investor Relations QIAGEN, +49-2103-29-11710, e-mail: solveigh.maehler at qiagen.com; Albert F. Fleury, Investor Relations, North America, QIAGEN, +1-301-944-7028, e-mail: albert.fleury at qiagen.com; Angela Duff, Abbott Investor Relations, +1-847-938-6894, angela.duff at abbott.com; Public Relations: Dr. Thomas Theuringer, Director Public Relations QIAGEN, +49-2103-29-11826, e-mail: thomas.theuringer at qiagen.com; Don Braakman, Abbott Public Affairs, +1-847-937-0080, Don.Braakman at abbott.com
Tags: Germantown, Illinois, Maryland And Des Plaines, October 12, QIAGEN, United States of America