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Potsdam, Germany, January 20, 2012

Signature Diagnostics to Present a novel Companion Diagnostic Product Predicting Response to Cetuximab in Colorectal Cancer at the ASCO 2012 Gastrointestinal Cancer Symposium in San Francisco

Signature Diagnostics AG announced today that the company was selected to present its novel companion diagnostics for predicting response to cetuximab in patients with colorectal cancer (CRC) of all stages at the ASCO 2012 Gastrointestinal Cancer Symposium in San Francisco on January 19-21, 2012.

The paper, "Use of wild-type (wt) KRAS, BRAF, and PIK3CA, combined with KRAS mutations (mut) in codon 13 and RNA expression level of amphiregulin (AREG) and epiregulin (EREG), to predict cetuximab (CE) response with high accuracy in colorectal cancer of all four Dukes' stages" will be presented at the General Poster Session on January 21, 8:00am-9:00am and 12:00-1:30pm.

This innovative proprietary companion diagnostic (CDx-Cetuximab) comprises the detection of the mutation status of KRAS, BRAF, PIK3CA and the RNA expression level of Amphiregulin (AREG) and Epiregulin (EREG) for the accurate prediction of response to Cetuximab in patients with CRC of all four stages. Wild-type PIK3CA, BRAF and KRAS combined with KRAS mutations in codon 13 and RNA expression of AREG und EREG predicts response to Cetuximab with a sensitivity of 94% and a specificity of 86%. The area under the curve (AUC) is 0.96.

This companion diagnostics combining mutation and RNA expression markers offers the highest accuracy in predicting response to cetuximab for patients with colorectal cancer of all four stages and warrants application in the clinical testing setting” said Prof. André Rosenthal, CEO of Signature Diagnostics.

About Signature Diagnostics AG

Signature Diagnostics AG is a molecular diagnostics company based in Potsdam, Germany, focusing on the development and commercialization of novel molecular oncology diagnostic products for early detection (screening) and prognosis of cancer. The company has completed development of its first two diagnostic products for colorectal cancer screening (“Detector C/C+”) and prognosis (“Predictor C”), which will be launched in 2012 in its own ISO 15189 certified service laboratory. Using its state-of-the-art technologies in tissue and blood sample collection, molecular pathology, Xenopatient™ platform, genome-wide profiling, data mining, and biostatistics, the company collaborates with clinical, pharmaceutical, and diagnostic partners. Signature Diagnostics sponsors and conducts large prospective, multicenter clinical trials with more than 33 primary care hospitals and several dozen colonoscopy centers in Germany to discover and validate biomarkers in oncology.