ColoAlert’s Novel mRNA Biomarkers Demonstrate Sensitivity, Specificity in Detecting CRC, Advanced Adenoma

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The novel mRNA biomarkers in the noninvasive ColoAlert^® screening test displayed sensitivity and specificity for detecting colorectal cancer (CRC) and advanced adenomas that could be precursors to CRC, according to data from the ColoFuture trial presented at the 2023 International Conference on Gastroenterology.^1,2

Findings showed that screening with ColoAlert using DNA and mRNA biomarkers in combination with a fecal immunochemical test (FIT) led to a sensitivity of 94.4% (95% CI, 81.3%-99.3%) for detecting CRC compared with 73.7% (95% CI, 56.9%-86.6%) for screening with FIT alone.² The specificity was 97.5% (95% CI, 92.9%-99.5%) and 93.7% (95% CI, 88.0%-97.2%), respectively.

Additionally, ColoAlert demonstrated a sensitivity of 80.0% (95% CI, 66.3%-90.0%) for detecting advanced adenomas compared with 29.1% (95% CI, 17.6%-42.9%) for FIT alone. The specificity rates were 95.2% (95% CI, 89.8%-98.2%) and 93.7% (95% CI, 88.0%-97.2%), respectively.

When accounting for both CRC and advanced adenomas, the sensitivity rates were 87.1% (95% CI, 78.5%-93.2%) for ColoAlert vs 47.3% (95% CI, 36.9%-57.9%) for FIT alone. The specificity rates were 92.9% (95% CI, 87.0%-96.7%) and 93.7% (95% CI, 88.0%-97.2%), respectively.

ColoAlert uses PCR-based, DNA and mRNA-based screening in combination with FIT and a machine learning/artificial intelligence–driven algorithm.

The prospective, multicenter ColoFuture trial was conducted in Germany and Norway, and it included participants between 40 and 85 years of age who were referred for a screening or diagnostic colonoscopy, or had a diagnosis of CRC and were treatment naïve.

Occult blood underwent FIT analysis, and collected stool samples underwent an automated silica-bead–based extraction method followed by quantitative reverse transcription PCR for novel mRNA and DNA biomarkers. Biomarkers analyzed included somatic BRAF, somatic KRAS, B2M, CEACAM5, ITGA6, MACC1, PTGS2, S100A4, and GAPDH.

Among all participants included in the study (n = 220), the mean age was 62.3 years. Participants were classified into groups that included normal (n = 117), non–advanced adenoma (n = 10), advanced adenoma (n = 55), and CRC (n = 38).

Patients with CRC who underwent pathology staging (n = 34) had stage 0 (n = 1), stage I (n = 4), stage II (n = 16), stage III (n = 11), or stage IV (n = 2) disease. The sensitivity rates for stage 0, stage I, stage II, stage III, and stage IV were 0%, 100%, 94%, 100%, and 100%, respectively.

Additionally, the sensitivity rate for high-grade dysplasia was 75% (n = 9/12).

Currently, ColoAlert is commercially available in select European Union countries.¹ The ReconAAsense study will serve as an FDA registration trial for potential marketing approval in the United States.

References

1. Mainz Biomed presents groundbreaking results of ColoFuture study. News release. Mainz Biomed. October 18, 2023. Accessed October 18, 2023. https://gateway.eqs.com/maily/online-version/a5cc2066-ad8c-4e55-af99-79e87c002c6a
2. Krammes L, Jungling A, Mahmood H, et al. A novel and noninvasive FIT, DNA, mRNA and machine learning / AI-based early colorectal cancer and advanced adenoma detection test: first interim data review of the international COLOFUTURE study. Presented at: 2023 International Conference on Gastroenterology; October 16-18, 2023; Paris, France.