Summary: Mainz Biomed unveiled findings from the eAArly DETECT study at Digestive Disease Week 2024, demonstrating high sensitivity and specificity of their multimodal screening test for early detection of colorectal cancer and advanced adenomas.


  1. The eAArly DETECT test achieved 97% sensitivity and specificity for colorectal cancer and 82% sensitivity for advanced adenomas.
  2.  This test integrates the Fecal Immunochemical Test, along with proprietary mRNA biomarkers, complemented by an AI and machine learning algorithm. 
  3. The study supports a significant improvement in non-invasive colorectal cancer screening, potentially shifting focus from cancer detection to prevention.

Mainz Biomed, a molecular genetics diagnostic company specializing in the early detection of cancer, unveiled key findings from its eAArly DETECT study during a poster presentation at the renowned Digestive Disease Week (DDW) 2024 in Washington D.C. The company was also awarded as a Poster of Distinction by the Digestive Disease Week judges.

Mainz Biomed’s Colorectal Cancer Screening Test

The eAArly DETECT study, conducted across multiple sites in the United States with participation from 21 specialized gastroenterology centers, enrolled 254 evaluable clinical subjects. The study results underscore the remarkable efficacy of Mainz Biomed’s innovative multimodal screening test. This test integrates the Fecal Immunochemical Test (FIT), along with proprietary mRNA biomarkers, complemented by an artificial intelligence (AI) and machine learning algorithm. Together, these components enable precise differentiation among colorectal cancer (CRC), advanced adenomas (AA), non-advanced adenomas, and samples with no pathological findings, says Mainz Biomed.

The poster titled ‘Novel Stool-based non-invasive early detection of colorectal cancer and precancerous lesions by classic FIT combined with nucleic acid-based biomarker signatures’ was presented by Lena Krammes, PhD, senior scientist at Mainz Biomed. 

Clinical Study Findings

Key findings of the eAArly DETECT clinical study include a sensitivity for colorectal cancer of 97% with a specificity of 97% and a sensitivity for advanced adenoma of 82%. Additionally, the data demonstrated that within the advanced precancerous lesion patients, 100% of those patients with high-grade dysplasia (advanced adenomas with a high likelihood of turning into cancer) were detected. Only one of the colorectal cancer patients was not detected at stage I of the disease. Resulting performance data confirms the outcome previously obtained from the separate European ColoFuture study and that this multimodal screening strategy reflects a substantial and meaningful improvement for CRC and especially AA detection, where improved sensitivity is urgently needed to decrease CRC incidence and mortality.

Further reading: Mainz Biomed Colorectal Cancer Diagnostic Part of FDA Trial

“The ability to detect advanced precancerous lesions and in particular advanced adenomas as part of a colorectal screening test is critical to drive a paradigm shift in current frontline screening options,” says Moritz Eidens, PhD, chief scientific officer at Mainz Biomed. “We know that patients with advanced adenomas have an increased risk of developing colorectal cancer. The significant improvement in AA sensitivity compared to other non-invasive tests currently available combined with the excellent sensitivity and specificity for CRC, allows us to accelerate the shift from cancer detection to prevention. Our mission is to transform current colorectal cancer screening practices, and ultimately to reduce cancer mortality rates worldwide”.