Mainz Biomed says it is preparing to launch a pivotal US trial of its next-generation colorectal cancer (CRC) screening test following strong early data—and has moved into the pancreatic cancer space with a strategic acquisition.

In a half-year update for the six months ending June 30, 2025, the molecular diagnostics company also confirmed it had regained full compliance with Nasdaq listing requirements and reported early progress on several R&D and commercial fronts.

The company, which specialises in non-invasive early cancer detection, is currently running its eAArly DETECT 2 feasibility study to evaluate the next generation of its CRC test. The product combines Mainz’s proprietary mRNA biomarkers, AI-driven algorithms, and the established FIT (faecal immunochemical test) to improve accuracy. The trial involves around 2,000 average-risk patients and builds on previous data that included both average and at-risk individuals.

CEO Guido Baechler said the study will lay the groundwork for the planned ReconAAsense pivotal trial to support a future FDA premarket approval (PMA) submission in 2026.

Pancreatic cancer programme gains momentum

In parallel, Mainz Biomed has entered the pancreatic cancer space through a licensing and option agreement with US-based Liquid Biosciences. The deal grants access to a panel of novel mRNA biomarkers identified using Liquid’s EMERGE platform, based on a study of 285 subjects—including 35 pancreatic cancer cases.

The panel achieved sensitivity of 95% and specificity of 98% for detecting pancreatic cancer in blood samples, the company reported. A confirmatory feasibility phase is now underway as part of Mainz’s PancAlert initiative, with the aim of developing a non-invasive screening test for early pancreatic cancer detection.

The project has also received a financial boost, with public funding secured through the Innovation and Technology Support Program of the ISB (the development bank of Rheinland-Pfalz), which will fund up to 50% of the project’s costs.

Commercial expansion and Nasdaq compliance

On the commercial front, Mainz struck two new international partnerships during H1 2025. The first sees ColoAlert—its existing DNA-based CRC screening product—launch in Switzerland through a partnership with Goldach-based diagnostics firm labor team w ag. The second is a technology agreement with UK-based EDX Medical Group, which will incorporate Mainz’s technology into its digital diagnostics portfolio.

Financially, Mainz Biomed completed a follow-on offering of 2 million units, raising gross proceeds of approximately $4 million. Each unit included an ordinary share (or pre-funded warrant), a five-year Series A warrant, and a one-year Series B warrant.

The company also confirmed that it had regained full compliance with Nasdaq Capital Market listing rules, having met both stockholder equity and minimum bid price requirements.