ColoAlert research could identify advanced adenomas among colorectal cancer patients
Mainz Biomed – a company specialising in the early detection of cancer – has announced that the first patient has been enroled in ‘eAArly DETECT’.
ColoAlert represents the company’s US extension of ColoFuture, a European feasibility study evaluating the integration of novel gene expression biomarkers.
ColoAlert involves a highly efficacious test for colorectal cancer (CRC) across Europe and in select international territories. ColoFuture/eAArly DETECT, meanwhile, are multi-location studies analysing the potential of these biomarkers to identify advanced adenomas – a specific type of pre-cancerous polyp often attributed to CRC.
Five novel gene expression biomarkers being evaluated in the eAArly DETECT study have been licensed from the Université de Sherbrooke. During the institution’s work, researchers tested several novel transcriptional biomarkers using colon cancer samples and precancerous lesions.
The targets chosen by Mainz Biomed provided the greatest sensitivity and specificity of detection and demonstrated an ability to identify curable precancerous colonic polyps, in addition to treatable early-stage CRC.
The eAArly DETECT study will subsequently evaluate the effectiveness of these biomarkers to enhance ColoAlert’s product specifications. This will ultimately extend its capability to include the identification of advanced adenomas while increasing ColoAlert’s rates of diagnostic specificity and sensitivity.
Mainz expects to complete enrolment for the eAArly Detect in Q1 2023 and targets reporting topline results in 1H 2023. Based on the study’s outcome, the company will determine which of the biomarkers are eligible for inclusion in the company’s US pivotal trial (ReconAAsense), which is on schedule to begin enrolling patients in 2023, with results expected in 2025.
Guido Baechler, chief executive officer of Mainz Biomed, reflected: “Given the transformational impact that integrating advanced adenoma detection will have on ColoAlert’s technical profile and ultimate role in helping CRC prevention and treatment, today’s milestone is important as we embark on the execution phase of this feasibility study,”.
“All of us involved with Mainz are excited by the prospect of incorporating these biomarkers into ReconAAsense, the US pivotal study to evaluate the clinical performance of ColoAlert, which we anticipate commencing patient enrolment in H1 2023,” he added.
ColoAlert detects CRC via a simple-to-administer test with a sensitivity and specificity nearly as high as the invasive colonoscopy. The test also utilises proprietary methods to analyse cell DNA for specific tumour markers.
Source link
#Mainz #recruits #patient #biomarker #research
