Mainz Biomed Reports Topline Results from Feasibility Study of Biomarker Panel in Pancreatic Cancer Project
Mainz Biomed (NASDAQ:MYNZ) reported topline feasibility results for a non-invasive, blood-based pancreatic cancer screening test using 18 licensed biomarkers. In a 30-subject cohort the leading panel achieved 100% sensitivity and 95% specificity, and the algorithm also detected precancerous lesions. These results align with earlier discovery/validation datasets that showed 95% sensitivity and 98% specificity. Mainz Biomed will plan a larger confirmatory study using banked retrospective samples, then a PCR-based validation study and potential future FDA submission, pending outcomes.
Mainz Biomed (NASDAQ:MYNZ) ha riportato risultati di fattibilità iniziali per un test di screening non invasivo basato sul sangue per il cancro pancreatico, utilizzando 18 biomarcatori autorizzati. In una coorte di 30 soggetti, il pannello leader ha ottenuto 100% di sensibilità e 95% di specificità, e l'algoritmo ha rilevato anche lesioni precancerose. Questi risultati si allineano con i set di dati di scoperta/validazione precedenti che hanno mostrato 95% di sensibilità e 98% di specificità. Mainz Biomed pianificherà uno studio di conferma più ampio utilizzando campioni archiviati retrospettivamente, poi uno studio di validazione basato su PCR e una potenziale futura presentazione alla FDA, in base agli esiti.
Mainz Biomed (NASDAQ:MYNZ) informó resultados de viabilidad de alto nivel para una prueba de cribado de cáncer de páncreas no invasiva basada en sangre, utilizando 18 biomarcadores licenciados. En una cohorte de 30 sujetos, el panel principal logró 100% de sensibilidad y 95% de especificidad, y el algoritmo también detectó lesiones precancerosas. Estos resultados se alinean con conjuntos de datos de descubrimiento/validación anteriores que mostraron 95% de sensibilidad y 98% de especificidad. Mainz Biomed planeará un estudio de confirmación más amplio utilizando muestras retrospectivas almacenadas, luego un estudio de validación basado en PCR y una posible futura presentación a la FDA, dependiendo de los resultados.
Mainz Biomed (NASDAQ:MYNZ) 비침습적 혈액 기반 췌장암 선별 검사에 대해 라이선스받은 18개 바이오마커를 사용한 상향 가능성(feasibility) 결과를 보고했습니다. 30명 코호트에서 주도 패널은 민감도 100%와 특이도 95%를 달성했으며, 알고리즘은 전암성 병변도 탐지했습니다. 이러한 결과는 이전의 발견/검증 데이터 세트와 일치하며 민감도 95%, 특이도 98%를 보여주었습니다. Mainz Biomed는 보관된 후향적 샘플을 사용한 더 큰 확정 연구를 계획하고, 이후 PCR 기반 검증 연구 및 잠재적인 FDA 제출을 향한 가능성을 고려합니다, 결과에 따라.
Mainz Biomed (NASDAQ:MYNZ) a publié des résultats de faisabilité de haut niveau pour un test de dépistage non invasif basé sur le sang du cancer du pancréas, utilisant 18 biomarqueurs autorisés. Dans une cohorte de 30 sujets, le panneau leader a atteint une sensibilité de 100% et une spécificité de 95%, et l’algorithme a également détecté des lésions précancéreuses. Ces résultats s’alignent sur des ensembles de données de découverte/validation antérieurs qui montraient une sensibilité de 95% et une spécificité de 98%. Mainz Biomed prévoit une étude de confirmation plus large utilisant des échantillons rétrospectifs conservés, puis une étude de validation basée sur PCR et une éventuelle soumission future à la FDA, selon les résultats.
Mainz Biomed (NASDAQ:MYNZ) meldete topline Machbarkeitsergebnisse für einen nicht-invasiven, blutbasierten Screening-Test auf Bauchspeicheldrüsenkrebs mit 18 lizenzierten Biomarkern. In einer Kohorte von 30 Probanden erzielte das führende Panel eine Empfindlichkeit von 100% und eine Spezifität von 95%, und der Algorithmus erkannte auch präkanzeröse Läsionen. Diese Ergebnisse stimmen mit früheren Entdeckungs-/Validierungsdatensätzen überein, die eine Empfindlichkeit von 95% und eine Spezifität von 98% zeigten. Mainz Biomed wird einen größeren bestätigenden Studienplan mit archivierten retrospektiven Proben erstellen, dann eine PCR-basierte Validierungsstudie und eine mögliche zukünftige FDA-Einreichung, abhängig von den Ergebnissen.
Mainz Biomed (NASDAQ:MYNZ) أبلغت عن نتائج جدوى رئيسية لاختبار فحص سرطان البنكرياس غير الغازي القائم على الدم باستخدام 18 علامة حيوية مرخّصة. في عينة مكوّنة من 30 مشاركاً، حقق النظام الرائد حساسية 100% وخصوصية 95%، كما اكتشف الخوارزمية آفات قبل السرطانية. تتماشى هذه النتائج مع مجموعات بيانات الاكتشاف/التحقق السابقة التي أظهرت حساسية 95% وخصوصية 98%. ستخطط Mainz Biomed لدراسة تأكيدية أوسع باستخدام عينات مرتجعة محفوظة، ثم دراسة تحقق قائمة على PCR واحتمال تقديمها المستقبلي لإدارة الغذاء والدواء الأمريكية FDA، اعتماداً على النتائج.
Mainz Biomed (NASDAQ:MYNZ) 报告了基于血液的非侵入性胰腺癌筛查测试的初步可行性结果，使用18个获许可的生物标志物。在30名受试者的队列中，领先的面板实现了100% 灵敏度和95% 特异性，算法还检测出前癌性病变。这些结果与早期发现/验证数据集一致，显示95% 灵敏度和98% 特异性。Mainz Biomed 将计划使用留存的回顾性样本进行更大规模的确认性研究，然后进行基于PCR的验证研究，并在结果公布后考虑未来提交FDA的可能性。
- Leading panel: 100% sensitivity in 30-subject cohort
- Leading panel: 95% specificity in 30-subject cohort
- Algorithm detected precancerous lesions as well as cancer
- Results consistent with prior 95% sens / 98% spec dataset
- Planned larger confirmatory study using banked retrospective samples
- Feasibility cohort size limited to 30 subjects
- Performance requires confirmation in a larger study
- No regulatory clearance yet; FDA submission is only potential
Insights
Topline feasibility shows very high sensitivity and specificity in a small cohort; next steps are larger confirmatory studies and PCR validation.
The study reports a leading biomarker panel with 100% sensitivity and 95% specificity in a 30-subject cohort, and references prior discovery/validation results of
Key dependencies and risks described include the small sample size (30 subjects) used for the feasibility readout and the reliance on larger confirmatory and validation studies to establish performance across stages of disease and pre‑cancerous lesions. Reproducibility across independent, larger cohorts and transition from the current assay approach to PCR are explicitly noted as necessary steps before clinical utility or regulatory consideration can be assessed.
Concrete near-term milestones to monitor are the planned larger confirmatory study using banked retrospective samples, subsequent PCR-based validation study, and any stated timelines or results from those studies; these will determine whether the initial high metrics generalize beyond the feasibility cohort.
Study Demonstrated a Sensitivity of
Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announces positive topline results from its feasibility study, examining a non-invasive blood-based screening test for the early detection of pancreatic cancer, initiated earlier this year. The study confirmed the strong clinical accuracy and utility of licensed proprietary biomarkers from Liquid Biosciences for developing an innovative screening test for pancreatic cancer. Researchers evaluated 18 licensed biomarkers across multiple candidate panels to streamline assay complexity. The leading panel achieved
These findings are consistent with the strong performance previously demonstrated in discovery and validation datasets, which achieved
Importantly, the algorithm developed by Liquid Biosciences not only distinguished pancreatic cancer from healthy controls but also successfully detected precancerous lesions that have the potential to develop into pancreatic cancer if left untreated. The ability to identify these lesions through a blood test opens the door to monitoring at-risk individuals, intervening earlier in the disease process, and ultimately reducing the incidence and mortality associated with pancreatic cancer.
“We are thrilled about the team’s progress in confirming the strong clinical results from our discovery study. What’s particularly exciting is that our algorithm and biomarker selection can identify neoplasms in blood. Delivering a blood-based test capable of detecting early stages of disease is a major step toward the early detection—and ultimately the elimination—of pancreatic cancer,” said Guido Baechler, CEO Mainz Biomed
Having confirmed the validity of a panel of candidate mRNA biomarkers with strong potential clinical relevance, Mainz Biomed will begin planning a larger clinical study to finalize biomarker selection using banked retrospective samples. This upcoming study will evaluate the biomarkers’ performance across different stages of pancreatic cancer and further investigate the ability to identify early various stages of cancer and pre-cancer, leveraging next-generation sequencing technologies.
Subject to the outcome of the larger confirmatory study, Mainz Biomed intends to proceed with a validation study using a larger cohort of blood samples using Polymerase Chain Reaction technology (PCR). This would be a critical step toward optimizing the test for potential clinical utility and preparing it for future regulatory considerations, including a possible submission to the U.S. Food and Drug Administration (FDA). The pancreatic cancer project is part of the Company’s broader strategy to develop accessible molecular diagnostics for early cancer detection, particularly in indications where current screening tools are limited or non-existent.
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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 its eAArly DETECT 2 clinical study in preparation for its pivotal FDA 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 in blood and stool samples. 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; (iii) the effect of the COVID-19 pandemic on the Company and its current or intended markets; and (iv) 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.
FAQ
What sensitivity and specificity did Mainz Biomed report for its pancreatic test (MYNZ) on October 8, 2025?
How many biomarkers and subjects were in Mainz Biomed's pancreatic feasibility study (MYNZ)?
Will Mainz Biomed (MYNZ) run larger studies after the October 8, 2025 results?
Did Mainz Biomed (MYNZ) report detection of precancerous lesions in the study?
Are Mainz Biomed's (MYNZ) pancreatic test results ready for clinical use or FDA approval?
How do these feasibility results compare to prior datasets cited by Mainz Biomed (MYNZ)?
