Signature Diagnostics AG to Present a Novel Companion Diagnostic Product Predicting Response to Cetuximab in Colorectal Cancer at the 102nd American Association for Cancer Research Meeting in Orlando

POTSDAM, GERMANY--(Marketwire - April 06, 2011) - Signature Diagnostics /

Signature Diagnostics to Present a novel Companion Diagnostic Product Predicting Response to Cetuximab in Colorectal Cancer at the 102nd AACR Meeting in Orlando . Processed and transmitted by Thomson Reuters ONE. The issuer is solely responsible for the content of this announcement.

Potsdam, Germany, April 6, 2011 - 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 102nd Annual Meeting of the American Association for Cancer Research (AACR) in Orlando on April 2-6, 2011.

The paper, "BRAF and PIK3CA mutations in addition to KRAS improve prediction of resistance to Cetuximab in a large panel of colon carcinoma xenografts" was presented at the late breaking poster session on April 5, 8:00am-12:00am.

This innovative proprietary companion diagnostic (CDx-Cetuximab) comprises the detection of the mutation status of PIK3CA and BRAF in addition to KRAS for the accurate prediction of response to Cetuximab, an approved anti-EGFR antibody, in patients with CRC of all four stages, especially in UICC stage II and III. Wild-type PIK3CA, BRAF and KRAS predicts response to Cetuximab with a sensitivity of 83% and a specificity of 76%. By addition of the KRAS gene 35G > A mutation to wild-type PIK3CA, BRAF, and KRAS the CD-Cetuximab predicts response to Cetuximab with an increased sensitivity of 94%.

"Today, the KRAS mutation status is the only companion diagnostics for predicting response to Cetuximab and Panitumumab in patients with advanced, metastatic colorectal cancer. Both drugs are not approved for treating patients with colorectal cancer of UICC stage II and III. Our novel companion diagnostic CD-Cetuximab comprises the mutation status of three genes, PIK3CA, BRAF and KRAS, and is highly accurate in predicting response to Cetuximab in patients with CRC of UICC stage II and III" said Prof. André Rosenthal, CEO of Signature Diagnostics. "The development of companion diagnostics that predict response to Cetuximab in CRC patients of UICC stage II and III, opens the way for novel pivotal trials, that may lead to label extension of anti-EGFR antibodies in the adjuvant setting of CRC."

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 2011 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.

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Signature Diagnostics Hermannswerder 20 A Potsdam Germany

Press release (PDF): http://hugin.info/143237/R/1504046/438920.pdf

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Source: Signature Diagnostics via Thomson Reuters ONE

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