Signature Diagnostics Announces Positive Study Results Using Predictor C to Predict Colorectal Cancer Progression

07-Jun-2010 - Germany

Signature Diagnostics AG announced 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.

"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.

https://www.bionity.com/en/news/118560/signature-diagnostics-announces-positive-study-results-using-predictor-c-to-predict-colorectal-cancer-progression.html