Mainz Biomed has initiated the ColoFuture clinical study to assess the integration of a new mRNA biomarkers portfolio into its ColoAlert test for colorectal cancer (CRC).
ColoAlert is an easy-to-use, non-invasive test designed to detect tumour DNA and CRC cases in the earliest stages from stool samples.
Last month, the company acquired an exclusive option to in-license the new gene expression (mRNA) biomarkers from the Universite de Sherbrooke in Canada.
These biomarkers have been shown to have the ability to detect curable precancerous colonic polyps and treatable early-stage CRC.
In the ColoFuture study, the mRNA biomarkers’ effectiveness will be assessed in regards to improving the technical profile of ColoAlert to include the detection of advanced adenomas (AA), a pre-cancerous polyp type often attributed to CRC.
The trial will also help in increasing ColoAlert’s rates of diagnostic sensitivity and specificity.
The study will recruit more than 600 male and female patients, in the age group 40 to 85 years, who are referred for a colonoscopy at four participating centres. Two of these centres are located in Norway, while the other two are in Germany.
The specificity and sensitivity rates for CRC with ColoAlert, along with the new mRNA biomarkers, will be determined as the study’s primary endpoints.
Specificity for advanced precancerous lesions in the colon, sensitivity for AA lesions in the colon and specificity for no colorectal finding (normal colon) will be determined as some of the secondary endpoints for the trial.
Mainz Biomed CEO Guido Baechler said: “Initiating the ColoFuture study is an exciting opportunity for the company, the patient and medical communities, as the outcome could be a game-changer for the role ColoAlert will play in the prevention and treatment of CRC. We look forward to reporting the study’s clinical results by early 2023.
“However, if the study’s results prove positive, it will be a transformative milestone for the company as it will solidify ColoAlert’s position as the premier at-home diagnostic tool for this deadly form of cancer.”
The company expects to conclude patient enrolment in the second half of the year and report the results of the ColoFuture study early next year.