NEW YORK – Mainz Biomed said Tuesday that it has received approval from an independent institutional review board for the trial protocol of its ReconAAsense study. The study, which will recruit 15,000 individuals across the US, is to evaluate the clinical performance of the firm's colorectal cancer early detection test in order to support a submission for review by the US Food and Drug Administration.
Mainz's ColoAlert assay combines analysis of DNA, mRNA, and fecal immunohistochemistry to identify cancer in asymptomatic individuals from a stool sample. The company currently markets the test across Europe and the United Arab Emirates.
In the new US study, Mainz aims to measure the test's sensitivity, specificity, positive predictive value, and negative predictive value in average-risk subjects for both CRC and its precursor, advanced adenomas.
Once enrollment commences, Mainz said ReconAAsense will continue until at least 73 evaluable subjects are diagnosed with colorectal cancer and at least 138 evaluable subjects are diagnosed with advanced adenoma. The firm anticipates reporting results in 2025.
The trial joins another recently announced effort, eAArly DETECT, which is a US extension of Mainz's European feasibility study, ColoFuture. The firm expects that effort, which is analyzing the potential of newly licensed biomarkers to improve ColoAlert even further, to complete enrollment early next year and report top-line results by the end of the first half of 2023. Based on the outcome, the company may pivot to include some or all of those additional biomarkers in ReconAAsense.
"We look forward to commencing the US regulatory approval process for our next-generation product and are passionate about bringing this easy-to-administer test to the US. In addition, we eagerly await results from the ColoFuture feasibility study, as the potential to include novel biomarkers to detect advanced adenomas will be a game changer for at-home CRC screenings," Mainz CEO Guido Baechler said in a statement.