Molecular genetics company Mainz Biomed has enrolled its first patient in an international clinical study assessing the potential combination of gene expression (mRNA) biomarkers with a diagnostic test for colorectal cancer.
The ColoFuture clinical study will see Mainz Biomed integrate a portfolio of novel gene expression (mRNA) biomarkers into its ColoAlert detection test for colorectal cancer (CRC).
ColoFuture is an international clinical trial featuring over 600 patients across two centres in Norway and two in Germany. The study aims to determine sensitivity and specificity rates for CRC with ColoAlert plus the new mRNA biomarkers. Patients will be included in the study based on a positive diagnosis of CRC or advanced precancerous lesions in the colon.
Mainz Biomed is expecting to complete enrolment during the second half of 2022 and is targeting reporting study results in early 2023.
Mainz Biomed acquired the mRNA biomarkers from the Université de Sherbrooke where researchers tested multiple novel transcriptional biomarkers using colon cancer samples and precancerous lesions.
The ColoFuture study will now evaluate the effectiveness of these biomarkers to enhance ColoAlert’s technical profile to extend its capability to include the identification of advanced adenomas (AA), a type of pre-cancerous polyp often attributed to CRC, while increasing ColoAlert’s rates of diagnostic sensitivity and specificity.
“The first patient in milestone marks the conclusion of several months of intensive preparatory work to ensure the trial is optimally managed and signifies the formal commencement of the study,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “This is a particularly exciting clinical trial for the Company and of course, the patient and medical communities as the outcome could potentially position ColoAlert as the gold standard at home screening test for this deadly form of cancer.”