Signature Diagnostics Will Commercialize First Microarray-Based Products for Detecting and Predicting Progression of Colorectal Cancer

Santa Clara, Calif. & Postdam, Germany – 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(R) 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 https://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 https://www.signature-diagnostics.de