Signature Diagnostics says it aims to launch its blood-based Detector C in vitro screening test for colorectal cancer by the end of 2010 or early 2011. Confirmation of launch plans coincides with the release of positive data from a prospective multicenter validation study. The full set of data is due for presentation at ASCO on June 6.
Dectector C uses Affymetrix technology to evaluate the expression of 202 genes that are active in white blood cells in response to tumor formation, Signature explains. The firm claims study data has shown that the assay demonstrates 90% sensitivity for all four cancer stages and a specificity of 88%. False negatives of just one in 872 tested individuals have been recorded, which is four times lower than the false-negative rates of other blood-based tests and seven times lower than the Hemoccult II test, Signature suggests.
“Detector C is the safest and most accurate blood-based screening test available, making it particularly well suited for population screening,” claims Professor André Rosenthal, Signature’s CEO. “The unprecedented low number of false negatives warrants its use prior to colonoscopy and as an alternative to inaccurate Hemoccult II tests.”
Based in Potsdam, Germany, Signature is exploiting a range of tissue/blood collection, pathology, tumor-profiling, and bioinformatics technologies to develop novel in vitro diagnostics for the prognosis and early detection of colorectal cancer. The firm is working in collaboration with clinical and diagnostic partners as well as with sponsors, and it carries out large prospective trials for the discovery and validation of RNA biomarkers in colorectal cancer.
Signature also offers a range of products and services to both clinical/academic and industrial clients. These include sigDISCOVERY, a collection of tissue collection, array-based discovery, molecular pathology, and protein sublocalization platforms for the discovery, validation, and clinical application of prognostic and drug response signatures; sigNATURE for the development of predictive diagnostic assays once prognostic or predictive drug response signatures have been identified and validated; and sigTARGET, a platform of tumor-expression databases in colorectal and lung cancer as well as other cancer indications. Signature also has a license from Affymetrix that allows it to offer customers a complete spectrum of array-based services in combination with the Affymetrix technology.