Signature Diagnostics to Use Affymetrix Microarray Technology for Advanced Colorectal Cancer Tests
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Signature Diagnostics will commercialize first microarray-based products for
detecting and predicting progression of colorectal cancer
Santa Clara, Calif. and Potsdam, Germany, June 28, 2010 -Affymetrix, Inc.
(NASDAQ: AFFX) and Signature Diagnostics AG (Signature Dx) today announced that
they have signed a Powered by Affymetrix(TM) (PbA) agreement. Under the
agreement, Signature Dx obtains a worldwide license to use Affymetrix(®)
microarray technology to develop and commercialize diagnostic and prognostic
colorectal cancer (CRC) tests.
Signature Dx plans to launch two microarray-based in-vitro diagnostic (IVD)
products by the fourth quarter of this year to enable earlier diagnosis and
improved prognosis for CRC. Approximately 396,000 people are diagnosed with CRC
annually in the five major European countries and the US, and millions more go
undetected because of limitations in current diagnosis methods. Signature Dx
will launch the tests in Europe and plans to seek US regulatory approval in the
future.
Detector C is a validated, non-invasive, blood-based early detection test that
has shown consistently high sensitivity of 90 percent for all four CRC stages
(including early stages), and a specificity of 88 percent. Predictor C is a
validated prognostic tissue test that predicts disease progression in stage II
and III CRC patients and been shown to identify half of all stage II/III
patients with a high risk of disease progression.
"Colorectal cancer is one of the most common cancers worldwide and our
innovative, multivariate IVD tests can significantly improve both the diagnosis
and prognosis of the disease," said André Rosenthal, PhD, Chief Executive
Officer of Signature Diagnostics. "Our novel Detector C blood screening product
together with Affymetrix' gene expression array technology brings CRC screening
to a new level of accuracy and sensitivity. This licensing agreement provides us
with the underlying microarray technology for our diagnostic products in
colorectal cancer."
"Signature Diagnostics' innovative colorectal cancer tests have the potential to
vastly improve diagnosis and lead to better-informed treatment decisions for
this disease," said Andrew Last, PhD, Executive Vice President and Chief
Commercial Officer at Affymetrix. "This Powered by Affymetrix agreement
demonstrates the importance of microarray technology in advancing healthcare and
further reinforces Affymetrix' leadership position in the global shift towards
personalized healthcare."
About Affymetrix
Affymetrix technology is used by the world's top pharmaceutical, diagnostic, and
biotechnology companies, as well as leading academic, government, and nonprofit
research institutes. More than 1,900 systems have been shipped around the world
and more than 21,000 peer-reviewed papers have been published using the
technology.
Affymetrix is headquartered in Santa Clara, Calif., and has manufacturing
facilities in Cleveland, Ohio, and Singapore.
The company has about 1,000 employees worldwide and maintains sales and
distribution operations across Europe and Asia. For more information about
Affymetrix, please visit www.affymetrix.com.
Affymetrix, the Affymetrix logo, and Powered by Affymetrix are trademarks or
registered trademarks of Affymetrix Inc.
About Signature Diagnostics AG
Signature Dx is a molecular diagnostics company based in Potsdam, Germany,
focusing on the development and commercialization of novel in-vitro diagnostic
(IVD) products for the prognosis and early detection (screening) of colorectal
cancer. Using its state-of-the-art technologies in tissue and blood sample
collection, molecular pathology, genome-wide tumor profiling technologies, data
mining, and biostatistics, the company collaborates with many clinical and
diagnostic partners. Signature Dx sponsors and conducts large prospective,
multicenter clinical trials with more than 25 primary care hospitals and several
dozen colonoscopy centers in Germany to discover and validate RNA biomarkers in
colorectal cancer and colorectal cancer screening. The company's first products,
Predictor C and Detector C, will be launched by the end of 2010 in its own ISO
15189 certified service lab. For more information about Signature Dx' colorectal
cancer tests, please visithttp://www.signature-diagnostics.de/.
About Colorectal Cancer Screening
The EU-5 and US screening population (aged 50 to 79) totals 170 million
individuals. Approximately 5.1 million individuals (3 percent) have an
undetected colorectal cancer (CRC). Only 396,000 CRC cases (7.8 percent) are
presently diagnosed annually (EU-5: 220,000, USA: 176,000). Classical screening
methods, including haemocult II (gFOBT) and colonoscopy, detect only 5 percent
of these 396,000 CRC patients. In 4.7 million individuals affected with CRC, the
asymptomatic cancer remains undetected.
In Germany, 73,000 patients are diagnosed with CRC every year. Due to the risks
and inconvenience associated with CRC colonoscopy screening (bleeding events,
colon perforations), patient participation is low (3-5 percent p.a.). Therefore,
CRC screening using colonoscopy results in the diagnosis of only 5,400 patients
each year. Furthermore, CRC screening, using gFOBT, is declining due to the
test's inaccuracy and the difficulties associated with collecting stool samples.
There is a great need for a non-invasive in-vitro diagnostic (IVD) that can
detect early stage CRC and serve as a reliable screening tool.
About Colorectal Cancer
CRC is the third most common cancer worldwide. In the five major European
countries and the USA, approximately 396,000 individuals are diagnosed with CRC
every year. Of these, 277,000 patients are diagnosed with stage II and stage III
CRC. Approximately 30 percent of the patients with stage II and roughly 50
percent of those with stage III experience disease progression including distant
metastasis of the liver and lung or local recurrence within three to five years
after surgery. If the cancer spreads to distant organs, the five years survival
rate is only 8 percent. Presently, there are no validated clinical parameters or
biomarkers in use to identify patients with a high risk of disease progression.
If this risk could be determined, a substantial number of patients with stage
II/III disease would benefit from adjuvant chemotherapy in addition to surgery.
Forward-looking statements
All statements in this press release that are not historical are
"forward-looking statements" within the meaning of Section 21E of the Securities
Exchange Act as amended, including statements regarding Affymetrix'
"expectations," "beliefs," "hopes," "intentions," "strategies," or the like.
Such statements are subject to risks and uncertainties that could cause actual
results to differ materially for Affymetrix from those projected. These and
other risk factors are discussed in Affymetrix' Form 10-K for the year ended
December 31, 2009, and other SEC reports for subsequent quarterly periods.
Affymetrix, Inc. Signature Diagnostics
Media contact: André Rosenthal
Bronwyn Barnett Chief Executive Officer
Senior Manager, Marketing Communications Hermannswerder 20A
Tel: 408-731-5293 14473 Potsdam, Germany
Bronwyn_Barnett(at)affymetrix.com Tel: +49-331-2000-208
PR(at)signature-diagnostics.de
Investor contact:
Doug Farrell
Vice President, Investor Relations
408-731-5285
[HUG#1427729]
--- End of Message ---
Signature Diagnostics
Hermannswerder 20 A Potsdam Germany
Press release (PDF): http://hugin.info/143237/R/1427729/375346.pdf
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Source: Signature Diagnostics via Thomson Reuters ONE
Unternehmensinformation / Kurzprofil:
Datum: 28.06.2010 - 15:00 Uhr
Sprache: Deutsch
News-ID 23114
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