Mainz Biomed N.V. (NASDAQ:MYNZ) has entered into a License and Option Agreement with Liquid Biosciences to access a portfolio of novel mRNA biomarkers for the non-invasive detection of pancreatic cancer through a simple blood test. The breakthrough technology demonstrated remarkable accuracy with 95% sensitivity and 98% specificity in detecting pancreatic cancer in blood samples.
Under the agreement announced on March 13, 2025, Mainz Biomed has secured exclusive rights to develop a test using Liquid's biomarkers, with a unilateral option to acquire exclusive global rights to the gene expression biomarkers. The financial terms include both a license fee and royalties on future revenues if the option is exercised.
"Securing the exclusive rights to license this portfolio of novel biomarkers is a major milestone and extension of our previously announced PancAlert program. It provides us with an extraordinary opportunity in the early detection and diagnosis of one of the most challenging cancers to treat," said Mainz Biomed's CEO, Guido Baechler. "We believe that this achievement marks a paradigm shift in how we can detect pancreatic cancer."
Innovative Technology and Validation Process
The discovery process leveraged Liquid Biosciences' proprietary EMERGE platform to identify clinically relevant mRNA biomarkers from a blood-based cohort of 285 subjects, including 35 pancreatic cancer patients. The robustness of these biomarkers was further confirmed through two additional independent cohorts, validating the strong clinical contribution of each biomarker identified in the initial discovery phase.
The technology combines these biomarkers with a proprietary algorithm developed by Liquid Biosciences, achieving the exceptional detection rates. If these statistical results prove replicable after integration into a new product, the test has the potential to become the most robust and accurate screening test for pancreatic cancer available on the market.
Addressing a Critical Unmet Need
Pancreatic cancer remains one of the deadliest forms of cancer, with a five-year survival rate of just 12% according to recent statistics. The poor prognosis is largely attributed to late diagnosis, as the disease often presents with vague symptoms that appear only after the cancer has advanced.
Current diagnostic methods for pancreatic cancer typically involve invasive procedures such as endoscopic ultrasound with fine-needle aspiration or surgical biopsies. These procedures carry risks and are usually performed only after imaging studies have identified suspicious lesions, which is often too late for effective intervention.
A non-invasive, blood-based test with high sensitivity and specificity could revolutionize pancreatic cancer screening, potentially enabling earlier detection when surgical intervention and treatment are more likely to be successful.
Development Roadmap
The companies plan to jointly develop this pancreatic cancer screening test, with efforts focused on:
- Enhancement of commercial assays
- Refinement of machine learning AI-based algorithms
- Preparation for potential FDA application and approval
This development builds upon Mainz Biomed's existing PancAlert program, expanding the company's portfolio of cancer detection technologies. Mainz Biomed already markets ColoAlert®, an early-detection diagnostic test for colorectal cancer, across Europe and is preparing for FDA clinical studies for US regulatory approval.
Technical Details of the Discovery
The biomarker discovery utilized sophisticated machine learning techniques through Liquid Biosciences' EMERGE platform. This approach allowed researchers to identify patterns in gene expression that distinguish pancreatic cancer patients from healthy individuals with remarkable accuracy.
The validation across multiple independent cohorts strengthens confidence in the findings, addressing a common challenge in biomarker research where promising initial results often fail to replicate in different patient populations.
The mRNA biomarkers identified appear to be specific to pancreatic cancer, potentially allowing for differentiation from other gastrointestinal conditions that might present with similar symptoms.
Market Implications
If successfully developed and approved, this blood test could significantly impact the pancreatic cancer diagnostic landscape. Early detection tools for pancreatic cancer represent a substantial market opportunity, given the current lack of effective screening methods and the high mortality rate associated with late diagnosis.
For Mainz Biomed, this agreement represents a strategic expansion of their cancer detection portfolio, complementing their existing colorectal cancer screening technology. The company's approach of developing non-invasive, accurate diagnostic tools positions them as a significant player in the molecular diagnostics market.
The development of this technology also highlights the growing importance of AI and machine learning in medical diagnostics, particularly in identifying complex biomarker patterns that might not be apparent through traditional analytical methods.
As the companies move forward with development and validation, healthcare providers and patients alike will be watching closely for a potential new tool in the fight against one of medicine's most challenging cancers.
