Innovative easy-to-use blood test shows promise for effective Colorectal Cancer Screening

BRIDGEWATER, N.J.- Patients are not willing to participate in colorectal cancer (CRC) screening using faecal occult blood tests, therefore, there is a need for the development of other test types that may improve screening uptake. Clinical Genomics presented research detailing the observed effectiveness of a next-generation, blood-based colorectal cancer screening test at the annual United European Gastroenterology Week (UEGW) meeting in Barcelona, Spain. The presentation is the first set of data to support the clinical validity of this next-generation screening innovation.

Specifically, the data demonstrate the performance of a circulating tumor DNA (ctDNA) blood test that detects three genes, BCAT1, IKZF1 & IRF4, that have been shown to be chemically modified, or hypermethylated, in colorectal cancer (CRC). An estimated one-third of adults in the United States aged 50 to 74 years have not been screened for CRC. The main goal of this research is to validate a test that is both easier to prescribe for providers and easier to comply with for all patients. Samples used in this study were acquired from Denmark, Australia, the Netherlands and Russia.

Results in this study of data from 1,621 subjects show that the performance of this next-generation blood-based screening test is comparable to currently available non-colonoscopy CRC screening tests like faecal immunochemical tests (FIT). Overall sensitivity reported for the assay for cancer (74%, N=184) compares to previous studies using FIT while maintaining high specificity (90%).

With a specificity of 90.1%, the 3-gene methylation ctDNA blood test had an overall sensitivity for CRC of 73.9% and was positive for 67.3% of early-stage cancer (stage I and II). The overall cancer positivity rate appears to be a function of tumour invasiveness. Based on the data reported herein, it is justified to proceed to the validation of this ctDNA assay in true screening populations.

At the presentation, Dr Lawrence LaPointe, Clinical Genomics' Chief Innovation Officer commented, "These results reinforce the significant potential of blood-based testing for colorectal cancer screening. With a specificity of 90%, the 3-gene methylation ctDNA blood test had an overall sensitivity for CRC of 74% and was positive for 67% of early-stage I and II cancers. These data support proceeding to the validation of our latest innovation in true screening populations," he concluded.

Betsy Hanna, Clinical Genomics' Chief Executive Officer and President said, "Clinical Genomics' mission is to save lives and reduce healthcare costs with easy-to-use and affordable tests for the detection and monitoring of colorectal cancer. Our goal is to use our proprietary technology to enable a new and powerful option for improved testing compliance and CRC detection through a standard blood test."