Signature Diagnostics Announces Positive Study Results Using Predictor C to Predict Disease Progression and Therapeutic Risk in Colorectal Cancer Patients

* Study data to be presented on June 6 at the Annual American Society of Clinical Oncology (ASCO) * Product Launch planned for Q4 2010 - Q1 2011 POTSDAM, Germany, June 4, 2010 - Signature Diagnostics AG announced today positive results from its international, prospective, multi-center performance evaluation study showing the diagnostic ability of Predictor C to distinguish between high-risk and low-risk disease progression.  Predictor C, a prognostic tissue test for UICC stage II / III colorectal cancer, uses Affymetrix technology to evaluate the expression of 32 genes that are involved in the disease's progression. The company will present the complete study data at the American Society of Clinical Oncology (ASCO) on June 6, between 2:00 - 6:00 PM, in Hall A2 (Abstract No: 3612). "Predictor C will have a significant impact on both the diagnosis and treatment of stage II and III colorectal cancer patients. Our multi-gene test enables physicians to predict colorectal cancer progression and thereby provide their patients with a more specific treatment following surgery," said André Rosenthal, CEO of Signature Diagnostics AG. "The ability of this test to predict colorectal cancer recurrence and the development of metastases fulfills a large unmet clinical need." Predictor C has been successfully validated using an independent set of frozen tumor tissue from 164 UICC stage II and III colorectal cancer patients. Within the five-year observation period, 72 patients experienced disease progression while no progression was seen in 92 patients.  The validation study demonstrated a sensitivity (S+) of 64 percent; a specificity (S-) of 63 percent; a positive predictive value (PPV) of 58 percent; and a negative predicted value (NPV) of 69 percent. In particular, the PPV of 58 percent underpins Predictor C's clinical utility and justifies adjuvant treatment for high-risk patients.  Predictor C identifies 51 percent of all stage II / III patients having a high-risk of disease progression. About Signature Diagnostics AG Signature Diagnostics AG 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 Diagnostics 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. About Colorectal Cancer Colorectal cancer (CRC) is the third most common cancer worldwide. In the five major European countries and the USA, approximately 400.000 individuals are diagnosed with CRC every year. Of these, 280.000 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. For questions, please contact: Jana Frömke Corporate Communications Signature Diagnostics Hermannswerder 20A 14473 Potsdam, Germany Tel: +49-331-2000-208 [HUG#1421183] Press release (PDF):