Mainz Biomed and Liquid Biosciences Make Groundbreaking Discovery of mRNA Biomarkers for Blood Based Detection of Pancreatic Cancer
Mainz Biomed (NASDAQ:MYNZ) has entered into a License and Option Agreement with Liquid Biosciences for novel mRNA biomarkers enabling non-invasive pancreatic cancer detection via blood tests. The groundbreaking discovery analysis demonstrated 95% sensitivity and 98% specificity in detecting pancreatic cancer.
The study involved multiple independent cohorts, with initial discovery using a blood-based cohort of 285 subjects, including 35 pancreatic cancer patients. The agreement grants Mainz exclusive license rights and an option to acquire global rights to the gene expression biomarkers, involving both a license fee and future revenue royalties.
The companies will jointly develop the pancreatic cancer screening test, focusing on commercial assay enhancement, algorithm refinement, and FDA application preparation. If statistical results prove replicable in a new product, this could position Mainz's test as the market's most robust pancreatic cancer screening solution.
Mainz Biomed (NASDAQ:MYNZ) ha stipulato un Accordo di Licenza e Opzione con Liquid Biosciences per nuovi biomarcatori mRNA che consentono la rilevazione non invasiva del cancro al pancreas tramite esami del sangue. L'analisi della scoperta innovativa ha dimostrato una sensibilità del 95% e una specificità del 98% nella rilevazione del cancro al pancreas.
Lo studio ha coinvolto più coorti indipendenti, con una scoperta iniziale utilizzando una coorte di 285 soggetti basata su sangue, inclusi 35 pazienti con cancro al pancreas. L'accordo concede a Mainz diritti di licenza esclusivi e un'opzione per acquisire diritti globali sui biomarcatori di espressione genica, prevedendo sia una tassa di licenza che royalties sui ricavi futuri.
Le aziende svilupperanno congiuntamente il test di screening per il cancro al pancreas, concentrandosi sul miglioramento dell'assay commerciale, sulla raffinazione degli algoritmi e sulla preparazione della domanda FDA. Se i risultati statistici si dimostreranno replicabili in un nuovo prodotto, questo potrebbe posizionare il test di Mainz come la soluzione di screening per il cancro al pancreas più robusta sul mercato.
Mainz Biomed (NASDAQ:MYNZ) ha firmado un Acuerdo de Licencia y Opción con Liquid Biosciences para nuevos biomarcadores de mRNA que permiten la detección no invasiva del cáncer de páncreas a través de análisis de sangre. El análisis del descubrimiento innovador demostró una sensibilidad del 95% y una especificidad del 98% en la detección del cáncer de páncreas.
El estudio involucró múltiples cohortes independientes, con un descubrimiento inicial utilizando una cohorte de 285 sujetos basada en sangre, incluidos 35 pacientes con cáncer de páncreas. El acuerdo otorga a Mainz derechos de licencia exclusivos y una opción para adquirir derechos globales sobre los biomarcadores de expresión génica, que implican tanto una tarifa de licencia como regalías sobre ingresos futuros.
Las empresas desarrollarán conjuntamente la prueba de detección de cáncer de páncreas, centrándose en la mejora del ensayo comercial, el refinamiento del algoritmo y la preparación de la solicitud a la FDA. Si los resultados estadísticos demuestran ser replicables en un nuevo producto, esto podría posicionar la prueba de Mainz como la solución de detección de cáncer de páncreas más robusta del mercado.
마인츠 바이오메드 (NASDAQ:MYNZ)가 액체 생명과학(Liquid Biosciences)과 비침습적인 췌장암 탐지를 위한 새로운 mRNA 바이오마커에 대한 라이선스 및 옵션 계약을 체결했습니다. 이 혁신적인 발견 분석은 췌장암 탐지에서 95%의 민감도와 98%의 특이도를 입증했습니다.
이 연구는 여러 독립적인 집단을 포함했으며, 초기 발견은 285명의 혈액 기반 집단을 사용하였고, 그 중 35명이 췌장암 환자였습니다. 이 계약은 마인츠에게 독점 라이선스 권한을 부여하고 유전자 발현 바이오마커에 대한 글로벌 권리를 획득할 수 있는 옵션을 포함하며, 라이선스 수수료와 향후 수익 로열티를 포함합니다.
양사는 상업적 분석 개선, 알고리즘 정교화 및 FDA 신청 준비에 집중하여 췌장암 선별 검사를 공동 개발할 것입니다. 통계적 결과가 새로운 제품에서 재현 가능하다고 입증된다면, 이는 마인츠의 검사를 시장에서 가장 강력한 췌장암 선별 솔루션으로 자리매김하게 할 수 있습니다.
Mainz Biomed (NASDAQ:MYNZ) a conclu un Accord de Licence et d'Option avec Liquid Biosciences pour de nouveaux biomarqueurs d'ARNm permettant la détection non invasive du cancer du pancréas via des tests sanguins. L'analyse de cette découverte révolutionnaire a démontré une sensibilité de 95% et une spécificité de 98% dans la détection du cancer du pancréas.
L'étude a impliqué plusieurs cohortes indépendantes, avec une découverte initiale utilisant une cohorte de 285 sujets basée sur le sang, dont 35 patients atteints de cancer du pancréas. L'accord accorde à Mainz des droits de licence exclusifs et une option d'acquisition de droits mondiaux sur les biomarqueurs d'expression génique, impliquant à la fois des frais de licence et des redevances sur les revenus futurs.
Les entreprises développeront conjointement le test de dépistage du cancer du pancréas, en se concentrant sur l'amélioration de l'essai commercial, le perfectionnement de l'algorithme et la préparation de la demande auprès de la FDA. Si les résultats statistiques se révèlent reproductibles dans un nouveau produit, cela pourrait positionner le test de Mainz comme la solution de dépistage du cancer du pancréas la plus robuste sur le marché.
Mainz Biomed (NASDAQ:MYNZ) hat einen Lizenz- und Optionsvertrag mit Liquid Biosciences für neuartige mRNA-Biomarker unterzeichnet, die eine nicht-invasive Erkennung von Bauchspeicheldrüsenkrebs durch Bluttests ermöglichen. Die bahnbrechende Entdeckungsanalyse zeigte eine 95%ige Sensitivität und 98%ige Spezifität bei der Erkennung von Bauchspeicheldrüsenkrebs.
Die Studie umfasste mehrere unabhängige Kohorten, wobei die erste Entdeckung eine blutbasierte Kohorte von 285 Probanden beinhaltete, darunter 35 Patienten mit Bauchspeicheldrüsenkrebs. Der Vertrag gewährt Mainz exklusive Lizenzrechte und eine Option zum Erwerb globaler Rechte an den Genexpressions-Biomarkern, die sowohl eine Lizenzgebühr als auch zukünftige Umsatzbeteiligungen umfassen.
Die Unternehmen werden gemeinsam den Screening-Test für Bauchspeicheldrüsenkrebs entwickeln, wobei der Fokus auf der Verbesserung des kommerziellen Assays, der Verfeinerung des Algorithmus und der Vorbereitung des Antrags bei der FDA liegt. Sollten die statistischen Ergebnisse in einem neuen Produkt reproduzierbar sein, könnte dies den Test von Mainz als die robusteste Screening-Lösung für Bauchspeicheldrüsenkrebs auf dem Markt positionieren.
- Exceptional detection rates: 95% sensitivity and 98% specificity for pancreatic cancer
- Exclusive licensing agreement with option for global rights
- Non-invasive blood-based testing method
- Validated through multiple independent cohorts
- Statistical results still need replication in new product development
- Additional costs through license fees and future royalty payments
- FDA approval still required
Insights
Mainz Biomed's exclusive licensing agreement with Liquid Biosciences represents a significant strategic expansion of their diagnostic portfolio. The company has secured rights to mRNA biomarkers for blood-based pancreatic cancer detection with exceptional 95% sensitivity and 98% specificity - metrics that significantly outperform typical cancer screening tools.
Pancreatic cancer diagnostics represent a critical unmet medical need due to typically late detection and poor survival rates. Early detection capability could position MYNZ as a leader in this specialized market. While specific financial terms weren't disclosed beyond a license fee and potential royalties, this agreement follows a smart staged-investment approach - allowing Mainz to validate the technology before potentially exercising their option for exclusive global rights.
The multiple-cohort validation approach (285 subjects including 35 pancreatic cancer patients, plus two additional independent cohorts) provides stronger evidence than typical early-stage biomarker studies. The company's explicit mention of preparation for "potential FDA application" signals a clear commercialization roadmap.
This development extends MYNZ's previously announced PancAlert program, demonstrating strategic continuity in building their cancer detection portfolio. For a company with
The reported 95% sensitivity with 98% specificity for pancreatic cancer detection represents exceptional performance metrics that exceed current standards. These figures, if replicable in larger studies, would position this blood test among the most accurate cancer screening tools available.
Pancreatic cancer presents unique diagnostic challenges - symptoms typically emerge only in advanced stages, and current screening methods lack sufficient accuracy for population-wide implementation. The ability to detect pancreatic malignancies through a simple blood test would address a significant diagnostic gap.
Methodologically, Liquid Biosciences' approach is notable. They've employed their EMERGE platform to identify mRNA biomarkers initially in a 285-subject cohort, then validated findings across two additional independent cohorts. This multi-cohort validation strengthens the credibility of their findings by demonstrating reproducibility.
The integration of machine learning algorithms with gene expression biomarkers represents a sophisticated technical approach. These AI-enhanced diagnostics typically improve over time through additional data inputs and algorithm refinement.
The development pathway appears well-structured, with plans for commercial assay enhancement and algorithm refinement before FDA submission. This systematic approach to validation increases the probability of successful regulatory approval, though the timeline remains undefined.
Discovery Analysis Demonstrates Transformative Sensitivity of
Mainz Biomed Enters into Exclusive Licensing Agreement for the Portfolio of mRNA Biomarkers, with Continued Development of Machine Learning AI-Based Algorithm Based on Liquid Biosciences EMERGE Platform
BERKELEY, Calif. and MAINZ, Germany, March 13, 2025 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”) , a molecular genetics diagnostic company specializing in the early detection of cancer, announced today it 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
“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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Forward-Looking Statements
Certain statements made in this press release are “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “anticipate”, “believe”, “expect”, “estimate”, “plan”, “outlook”, and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements reflect the current analysis of existing information and are subject to various risks and uncertainties. As a result, caution must be exercised in relying on forward-looking statements. Due to known and unknown risks, actual results may differ materially from the Company’s expectations or projections. The following factors, among others, could cause actual results to differ materially from those described in these forward-looking statements: (i) the failure to meet projected development and related targets; (ii) changes in applicable laws or regulations; and (iii) other risks and uncertainties described herein, as well as those risks and uncertainties discussed from time to time in other reports and other public filings with the Securities and Exchange Commission (the “SEC”) by the Company. Additional information concerning these and other factors that may impact the Company’s expectations and projections can be found in its initial filings with the SEC, including its annual report on Form 20-F filed on April 9, 2024. The Company’s SEC filings are available publicly on the SEC’s website at www.sec.gov. Any forward-looking statement made by us in this press release is based only on information currently available to Mainz Biomed and speaks only as of the date on which it is made. Mainz Biomed undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise, except as required by law.
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