On March 23, 2021 Universal Diagnostics (UDX), an in-vitro diagnostics company developing minimally-invasive, blood-based solutions for detecting cancer early, reported that it has started a prospective, multi-center observational study in the US for its investigational advanced adenoma (precursor lesions) and colorectal cancer (CRC) detection blood test (Press release, Universal Diagnostics, MAR 23, 2021, View Source [SID1234577045]). UDX is performing this study to evaluate the performance of a preliminary panel of biomarkers for detecting colorectal cancer and advanced adenomas in the US population and to provide supporting data for the development of the final assay.
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The study, called USOPTIVAL, has been designed to collect blood samples and clinical data from 1,100 subjects, aged 45-84, who have a suspected advanced adenoma or have newly diagnosed with CRC scheduled for resection surgery. A second cohort of subjects who are at average-risk of CRC and are scheduled for routine colonoscopy examination will also be included. This prospective study will be performed at approximately 17 clinical sites. Further details about USOPTIVAL can be found here.
"The start of USOPTIVAL is our first in the US, so is an important milestone in the development of our blood test for adenomas and early-stage colorectal cancer. In addition, the study will enable us to build our clinical/medical network in preparation of our pivotal clinical study later," said Juan Martínez-Barea, Co-Founder and President of Universal Diagnostics. "USOPTIVAL is scheduled to be completed by the end of 2021, enabling us to conduct the pivotal study of our CRC/AA test."
About the Colorectal Cancer and Advanced Adenoma Test
UDX’s first product is a simple, non-invasive and accurate blood-based screening test that allows early-stage colorectal cancer detection and cancer prevention through advanced adenoma detection. Using profiling of DNA methylation changes in large number of tissue and plasma samples using next-generation sequencing (NGS) approach, UDX has identified and quantified a proprietary panel of biomarkers that has been combined into targeted assays that have shown 77% sensitivity for colorectal cancer, 62.5% sensitivity of adenomas and 88-90% specificity and tissue of origin accuracy across different verification studies.