Next-Generation ColoAlert Screening Test Shows High Sensitivity, Specificity for CRC and Adenoma Detection

Guido Baechler

The integration of novel mRNA biomarkers into a next-generation version of the ColoAlert^® screening test was highly sensitive and specific for colorectal cancer (CRC) and advanced adenoma, according to topline results from a pooled study of patients from the ColoFuture and eAArly DETECT trials.¹

The approach had 92% sensitivity and 90% specificity rates for CRC, with a best-in-class sensitivity of 82% for advanced adenoma compared with existing commercial products. These findings confirm previously reported positive efficacy data with the test.

The pooled analysis comprised 690 evaluable patients across 21 sites in the United States (US) and 9 sites in Europe. Patient outcomes were compared with the results from the next-generation test incorporating novel mRNA biomarkers and fecal immunochemical test (FIT).

Mainz Biomed N.V., the developers of ColoAlert, plan to report findings from this study at a major medical conference during the second quarter of 2024.

“We conducted this pooled study to fine-tune the minimal biomarker set to be used to optimize sensitivity and specificity of the results in Mainz Biomed’s next-generation CRC screening tool. The new data read-out demonstrates that our next-generation product candidate for early-stage CRC detection utilizing mRNA biomarkers, a FIT test and a proprietary AI algorithm has consistently delivered high sensitivity and specificity for both advanced adenomas and CRC,” Guido Baechler, chief executive officer and director of Mainz Biomed.

ColoAlert^® is a non-invasive, at-home CRC screening kit that analyzes tumor DNA using polymerase chain reaction–based technology to detect tumors. The test offers superior early detection compared with fecal occult blood tests and detects more CRC cases than other stool tests, thereby allowing for earlier diagnosis.

The product is currently commercially available in select countries in the European Union. To potentially obtain marketing approval in the US, ColoAlert will undergo evaluation in the planned FDA registration ReconAAsense trial.

“[ColoAlert’s] strong performance is particularly noteworthy as the pooling a significantly higher number of patients, namely 2 entirely separate patient cohorts from 2 continents as well as previously unexamined patient samples,” Baechler continued in the press release. “Hence these results represent a critical milestone on our path to launching our FDA premarket approval pivotal study ReconAAsense, which is planned to recruit up to 15,000 patients.”

The company concludes that the ability to detect advanced adenomas in a pre-cancerous stage using ColoAlert has the potential to revolutionize CRC diagnostics by enabling early intervention before polyps can develop into cancer.

ColoFuture

ColoFuture was an international study assessing whether the integration of a portfolio of mRNA biomarkers from the Université de Sherbrooke could improve ColoAlert’s ability to identify adenomas, as well as its diagnostic sensitivity and specificity for CRC.2 Patients between 40 and 85 years of age who were either referred for a screening or diagnostic colonoscopy or were already diagnosed with colorectal adenocarcinoma but were treatment naive were enrolled across participating centers in Germany, Norway, and Denmark.

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

Patients were required to submit samples from 1 stool collection prior to colonoscopy or treatment. Based on colonoscopy results and applicable pathology reports, patients were sorted into 1 of 4 groups: colorectal adenocarcinoma, advanced precancerous lesions in the colon or rectum, non-advanced adenoma, or normal.

According to findings from an interim analysis of ColoFuture (n = 220), the screening test demonstrated 94% sensitivity and 97% specificity rates among patients with CRC; the sensitivity was 81% for those with advanced adenoma.²

eAArly DETECT

The US-based eAArly DETECT study evaluated 254 evaluable patients who were at least 45 years of age across 21 sites.3 The study had a comparable design to that of its European counterpart, ColoFuture. Patients were required to provide a stool sample prior to undergoing a colonoscopy to either screen for average-risk CRC; follow up on a positive non-invasive test, imaging, or symptoms; or prior to treatment administration in patients who had been previously diagnosed with CRC.

After information from the colonoscopy and any applicable histopathology was obtained, patients were classified into the following groups: CRC, advanced adenoma, non-advanced adenoma, no findings, or non-CRC.³

Topline results from eAArly DETECT demonstrated 97% sensitivity and specificity rates for CRC and an 82% sensitivity rate for advanced adenoma confirming and surpassing the positive results from ColoFuture.³

References

1. Mainz Biomed reports positive topline results from pooled study evaluating novel mRNA biomarkers and proprietary AI algorithm for integration into Pivotal FDA PMA Clinical trial for next generation colorectal cancer diagnostic. News Release. Mainz Biomed. April 25, 2024. Accessed April 25, 2024. https://www.globenewswire.com/news-release/2024/04/25/2869737/0/en/Mainz-Biomed-Reports-Positive-Topline-Results-from-Pooled-Study-Evaluating-Novel-mRNA-Biomarkers-and-Proprietary-AI-Algorithm-for-Integration-into-Pivotal-FDA-PMA-Clinical-Trial-fo.html
2. Mainz Biomed’s ColoFutureStudy, evaluating its novel mRNA biomarkers, reports groundbreaking topline results demonstrating sensitivity for colorectal cancer of 94% with specificity of 97% and advanced adenoma sensitivity of 81%. News release. Mainz Biomed. September 13, 2023. Accessed April 25, 2024. https://mainzbiomed.com/mainz-biomeds-colofuture-study-evaluating-its-novel-mrna-biomarkers-reports-groundbreaking-topline-results-demonstrating-sensitivity-for-colorectal-cancer-of-94-with-specificity-of-97-and-a/
3. Mainz Biomed reports positive topline results from U.S. eAArly DETECT study evaluating novel mRNA biomarkers. News Release. Mainz Biomed. December 5, 2023. Accessed April 25, 2024. https://mainzbiomed.com/mainz-biomed-reports-positive-topline-results-from-u-s-eaarly-detect-study-evaluating-novel-mrna-biomarkers/