We are validating Signal-C®, a blood-based colorectal cancer screening test able to detect colorectal cancer and pre-cancerous lesions (Advanced Adenomas) with high sensitivity and specificity.
With more than 1.9 million new colorectal cancer cases and 935,173 deaths, CRC is the 3rd most common cancer in men and 2nd most common cancer in women. It is also 2nd leading cause of cancer deaths for men and women in the U.S.(1)
Universal DX first blood test, Signal-C®, accurately detects colorectal cancer with sensitivity of 93% and specificity of 92%(2). Signal-C® is also focused on the detection of pre-cancerous lesions (Advanced Adenomas), with 54% sensitivity and 92% specificity(2). This is an important differentiating factor that allows Signal-C® not only to detect cancer but to prevent it.
(1) Source: Globocan · Global Cancer Statistics 2020.
(2) Results presented at the DDW 2023.
Universal DX has initiated the clinical validation study of Signal-C® in accordance with FDA requirements. The objective of this study is to evaluate the performance characteristics of Signal-C®, a plasma circulating free-DNA test, to detect colorectal cancer and advanced precancerous lesions in an average-risk screening population of 45-84 years old.