Novel mRNA Biomarker Integration Boosts Sensitivity, Specificity of ColoAlert in Detecting CRC

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The integration of novel mRNA biomarkers into the ColoAlert® screening test resulted in high sensitivity and specificity for colorectal cancer.

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The integration of novel mRNA biomarkers into the ColoAlert® screening test resulted in high sensitivity and specificity for colorectal cancer (CRC), according to topline results from the ColoFuture trial.

Findings showed that among 220 patients included in the interim analysis, the screening test demonstrated a 94% sensitivity for CRC with a specificity of 97%. For advanced adenoma, the sensitivity was 81%.

“The data generated from the ColoFuture study exceeded our expectations. As we look forward to publishing and presenting the full dataset at a forthcoming medical conference, we eagerly await the outcome from our eAArly DETECT clinical trial which remains on track to report results in [the fourth quarter] of [2023],” Guido Baechler, chief executive officer of Mainz Biomed, stated in a news release.

In ColoFuture, investigators set out to determine whether the integration of a portfolio of mRNA biomarkers, acquired from the Université de Sherbrooke, could potentially enhance ColoAlert’s capability to identify advanced adenomas and increase the diagnostic sensitivity and specificity rates for CRC.

The international study enrolled patients between 40 and 85 years of age from participating centers in Germany, Norway, and Denmark. The study included patients who were referred for a screening or diagnostic colonoscopy, and those with treatment-naïve colorectal adenocarcinoma. Patients were required to submit samples from 1 stool collection prior to colonoscopy or treatment.

Based on the colonoscopy results and any applicable pathology report from biopsy, patients were sorted into 1 of 4 groups:

Colorectal adenocarcinoma
Advanced precancerous lesions in the colon or rectum
Non-advanced adenoma
Normal

Each stool sample was then tested with ColoAlert featuring the mRNA biomarkers. “Mainz Biomed specifically selected those mRNA biomarkers which demonstrated not just the ability to detect a disease signal from samples of patients who were known to have CRC, but also the unique potential to identify a signal from samples of patients with advanced adenomas,” according to the press release.

The primary end points of the study were to determine sensitivity and specificity for colorectal adenocarcinoma. Secondary and exploratory end points included the sensitivity and specificity for detecting advanced precancerous lesions in the colon.

“The power to detect lesions in a pre-cancerous stage can change the entire CRC diagnostic landscape,” according to Mainz Biomed. “If advanced adenomas are identified early, they are curable. By treating the patient before the polyps can progress to a cancerous stage, CRC can be prevented.”