eAArly DETECT topline data ‘confirm, surpass’ ColoFuture for biomarker accuracy in CRC
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Topline findings from the eAArly DETECT trial showed Mainz Biomed’s novel mRNA biomarkers boasted a sensitivity and specificity of 97% for detection of colorectal cancer, and an 82% sensitivity for advanced adenomas detection.
Further, results from the trial “not only confirm but even surpass the good results from [the] ColoFuture” trial, which reported a sensitivity of 94% for CRC with specificity of 97% and an 80% sensitivity for advanced adenoma sensitivity, the release noted. The company reported that the results support the addition of these biomarkers in the next generation of its ColoAlert CRC screening test.
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“The eAArly DETECT and ColoFuture study read-outs not only represent an outstanding result for the company but also for CRC disease treatment and personal health care management,” Guido Baechler, CEO of Mainz Biomed, said in the release. “The results offer the unique promise of a self-administered screening tool with highly effective detection of adenomas (AA), a type of pre-cancerous polyp often attributed to this deadly disease. Upgrading the technical configuration of our at-home CRC screening test to include AA diagnostic capability represents a major innovation in the field of CRC diagnostics.”
According to the release, the mRNA biomarkers used in both trials were acquired from the University of Sherbrooke in Quebec, Canada, in January 2022, hoping to augment the ColoAlert’s profile to enhance its ability to detect advanced adenomas. Mainz Biomed chose this specific portfolio which showed “not just the ability to detect a disease signal from samples of patients who were known to have colorectal cancer, but also the unique potential to identify a signal from samples of patients with advanced adenomas.”
The eAArly detect trial, similarly to its European counterpart, the ColoFuture study included 254 patients aged 45 years or older, who were referred to a colonoscopy either to screen for CRC, to follow up on a positive non-invasive test, imaging or symptoms, or CRC was already identified but before any treatment was administered. Patients provided a stool sample in advance of the colonoscopy and based on pathology review were classified as either having CRC, advanced adenoma, non-advanced adenoma or no findings, or non-colorectal cancer.
Results were then compared with the results from the ColoAlert test with the incorporated novel mRNA biomarkers, the release stated.
The novel mRNA biomarkers exhibited a sensitivity of 97% in CRC as well as a specificity of 97%, with a sensitivity for advanced adenomas of 82%, the release stated.
The company noted the results from both the ColoFuture and eAArly DETECT trials support the use of the portfolio of novel mRNA biomarkers in ReconAAsense, a pivotal FDA premarket approval clinical trial set to begin enrollment in mid-2024.
“We are excited to present the full dataset at an upcoming medical conference and ramp-up preparations to commence patient enrollment in ReconAAsense, our pivotal FDA pre-market approval trial,” Baechler said in the release. “If successful, this will position a next generation ColoAlert as the most robust and accurate at-home CRC diagnostic screening test on the market.”
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