Signature Diagnostics AG to Use Affymetrix (Bedford, Massachusetts) Microarray Technology for Advanced Colorectal Cancer 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 visit http://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.
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Affymetrix, Inc. Media contact: Bronwyn Barnett, 408-731-5293 Senior Manager, Marketing Communications Bronwyn_Barnett@affymetrix.com or Investor contact: Doug Farrell, 408-731-5285 Vice President, Investor Relations or Signature Diagnostics André Rosenthal, +49-331-2000-208 Chief Executive Officer PR@signature-diagnostics.de