Signature Diagnostics AG has recently announced positive results from its multi-center, prospective clinical examination for validating Detector C, an in-vitro diagnostic screening device. Detector C, a blood-based and non-invasive screening test, is used to detect colorectal cancer in its early stage.
The test utilizes the Affymetrix technology for evaluation of the expression of the genes in white blood cells. The number of these genes is 202. This evaluation is in response to the tumor’s formation and growth. The test depicted a consistently large 90% sensitivity for all four cancer phases as well as the early phases, along with 88% specificity.
Signature Diagnostics will be making a presentation related to the total study data on June 6 during the American Society of Clinical Oncology (ASCO) event.
Detector C was validated successfully by utilizing an independent group of 343 blood samples. These blood samples included 133 samples received for patients aged over 55 and undergoing screening with colonoscopy and 210 samples of patients who have already been confirmed with all the four phases of colorectal cancer. The potential validation analysis depicted 0.9 sensitivity. Detector-C could also identify high-grade intraepithelial neoplasia with 0.66 sensitivity.
Detector C depicted low false negative rate that was just one out of 872 tested patients. This figure is four times lesser as compared to the false negative rates obtained on other tests based on blood.