Discovery Analysis Demonstrates Transformative Sensitivity of 95% with Specificity of 98% for the Detection of Pancreatic Cancer in Blood Samples
BEMainz Biomed N.V. recently announcedit has entered into a License and Option Agreement (the “Agreement”) with Liquid Biosciences (“Liquid”) to access a portfolio of novel mRNA biomarkers for the non-invasive detection of pancreatic cancer with a blood test. The parties, under the Agreement, plan to develop this blood-based test for potential future FDA applications.
Under the terms of the Agreement, the Company has the rights to develop a test using Liquid’s biomarkers through an exclusive license with the unilateral option to acquire the exclusive global rights to the gene expression biomarkers which have demonstrated a high degree of effectiveness in detecting pancreatic cancer. The financial terms of the Agreement include both a license fee and a royalty on future revenues in the event of the exercise of the option.
The discovery process included multiple independent pancreatic cancer study cohorts. Liquid used their proprietary EMERGE platform to identify a panel of clinically relevant mRNA biomarkers from a blood-based cohort of 285 subjects with 35 pancreatic cancer patients. Liquid further confirmed the biomarkers with two additional, independent cohorts, confirming the strong clinical contribution of each biomarker shown in the initial discovery phase. In the analysis, the biomarkers coupled with the proprietary algorithm developed by Liquid, achieved overall sensitivity of 95% and a 98% specificity for the detection of pancreatic cancer. If the statistical results are replicable after the integration into a new product, it has the potential to ultimately position the Company’s test to be the most robust and accurate screening test for pancreatic cancer on the market.
“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. We believe that this achievement marks a paradigm shift in how we can detect pancreatic cancer,” said Mainz Biomed’s CEO, Guido Baechler.
The parties plan to jointly develop this pancreatic cancer screening test, which will include enhancement of commercial assays, refinement of algorithms, and preparation for potential FDA application and approval.
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About Mainz Biomed NV
Mainz Biomed develops market-ready molecular genetic diagnostic solutions for life-threatening conditions. The Company’s flagship product is ColoAlert®, an accurate, non-invasive and easy-to-use, early-detection diagnostic test for colorectal cancer. ColoAlert® is marketed across Europe. The Company is currently running a development study to finalize with the next gen CRC screening test as preparation for the pivotal FDA clinical study for US regulatory approval. Mainz Biomed’s product candidate portfolio also includes PancAlert, an early-stage pancreatic cancer screening test based on real-time Polymerase Chain Reaction-based (PCR) multiplex detection of molecular-genetic biomarkers. To learn more, visit mainzbiomed.com or follow us on LinkedIn, Twitter and Facebook.
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