Mainz Biomed Enrolls First Patient in Its eAArly DETECT 2 Clinical Study
Mainz Biomed (NASDAQ:MYNZ) has enrolled its first patient in the eAArly DETECT 2 clinical study, a significant milestone in evaluating their next-generation colorectal cancer (CRC) test. The study will assess approximately 2,000 average-risk patients and combines proprietary mRNA biomarkers, an AI-developed algorithm, and a FIT test.
The study aims to validate previous feasibility results and support the transition from CRC screening to prevention. Enrollment is expected to complete in H2 2025, with top-line results targeted for Q4 2025. The outcome will help finalize protocols for ReconAAsense, the company's U.S. pivotal study planned for 2026.
The test incorporates five novel gene expression biomarkers acquired from Sherbrooke University in 2022, which have shown ability to identify both advanced adenomas (precancerous colonic polyps) and early-stage CRC. The study seeks to enhance diagnostic sensitivity and specificity for early-stage CRC detection.
Mainz Biomed (NASDAQ:MYNZ) ha arruolato il suo primo paziente nello studio clinico eAArly DETECT 2, un traguardo significativo nella valutazione del loro test di nuova generazione per il cancro colorettale (CRC). Lo studio valuterà circa 2.000 pazienti a rischio medio e combina biomarcatori mRNA proprietari, un algoritmo sviluppato con intelligenza artificiale e un test FIT.
L'obiettivo dello studio è convalidare i risultati di fattibilità precedenti e supportare la transizione dallo screening del CRC alla prevenzione. Si prevede che l'arruolamento si completi nella seconda metà del 2025, con risultati preliminari previsti per il quarto trimestre del 2025. L'esito aiuterà a finalizzare i protocolli per ReconAAsense, lo studio cruciale dell'azienda negli Stati Uniti pianificato per il 2026.
Il test incorpora cinque nuovi biomarcatori di espressione genica acquisiti dalla Università di Sherbrooke nel 2022, che hanno dimostrato la capacità di identificare sia adenomi avanzati (polipi colici precancerosi) che CRC in fase iniziale. Lo studio mira a migliorare la sensibilità e la specificità diagnostica per la rilevazione del CRC in fase precoce.
Mainz Biomed (NASDAQ:MYNZ) ha inscrito a su primer paciente en el estudio clínico eAArly DETECT 2, un hito significativo en la evaluación de su prueba de cáncer colorrectal (CRC) de nueva generación. El estudio evaluará aproximadamente 2,000 pacientes de riesgo promedio y combina biomarcadores de mRNA patentados, un algoritmo desarrollado por inteligencia artificial y una prueba FIT.
El objetivo del estudio es validar resultados de viabilidad previos y apoyar la transición de la detección de CRC a la prevención. Se espera que la inscripción se complete en la segunda mitad de 2025, con resultados preliminares previstos para el cuarto trimestre de 2025. El resultado ayudará a finalizar los protocolos para ReconAAsense, el estudio pivotal de la empresa en EE. UU. planeado para 2026.
La prueba incorpora cinco biomarcadores novedosos de expresión génica adquiridos de la Universidad de Sherbrooke en 2022, que han demostrado la capacidad de identificar tanto adenomas avanzados (pólipos colorrectales precoces) como CRC en etapa temprana. El estudio busca mejorar la sensibilidad y especificidad diagnóstica para la detección de CRC en etapa temprana.
Mainz Biomed (NASDAQ:MYNZ)는 eAArly DETECT 2 임상 연구에 첫 번째 환자를 등록하였으며, 이는 차세대 대장암(CRC) 검사의 평가에서 중요한 이정표입니다. 이 연구는 약 2,000명의 평균 위험 환자를 평가하며, 독점적인 mRNA 바이오마커, AI 개발 알고리즘 및 FIT 검사를 결합합니다.
이 연구의 목표는 이전의 타당성 결과를 검증하고 CRC 검진에서 예방으로의 전환을 지원하는 것입니다. 등록은 2025년 하반기에 완료될 것으로 예상되며, 2025년 4분기에 주요 결과가 목표로 하고 있습니다. 이 결과는 2026년 계획된 미국의 주요 연구인 ReconAAsense의 프로토콜을 최종화하는 데 도움이 될 것입니다.
이 검사는 2022년에 셔브룩 대학교에서 획득한 다섯 가지 새로운 유전자 발현 바이오마커를 포함하고 있으며, 이는 진행된 선종(전암성 대장 용종)과 초기 단계 CRC를 식별하는 능력을 보여주었습니다. 이 연구는 초기 단계 CRC 탐지를 위한 진단 민감도와 특이성을 향상시키는 것을 목표로 합니다.
Mainz Biomed (NASDAQ:MYNZ) a inscrit son premier patient dans l'étude clinique eAArly DETECT 2, une étape importante dans l'évaluation de leur test de nouvelle génération pour le cancer colorectal (CRC). L'étude évaluera environ 2 000 patients à risque moyen et combine des biomarqueurs d'ARNm propriétaires, un algorithme développé par IA et un test FIT.
L'objectif de l'étude est de valider les résultats de faisabilité précédents et de soutenir la transition du dépistage du CRC à la prévention. L'inscription devrait être terminée au second semestre 2025, avec des résultats préliminaires ciblés pour le quatrième trimestre 2025. Le résultat aidera à finaliser les protocoles pour ReconAAsense, l'étude pivot de l'entreprise prévue pour 2026 aux États-Unis.
Le test intègre cinq biomarqueurs d'expression génique novateurs acquis de l'Université de Sherbrooke en 2022, qui ont montré leur capacité à identifier à la fois des adénomes avancés (polypes coliques précoces) et des CRC à un stade précoce. L'étude vise à améliorer la sensibilité et la spécificité diagnostiques pour la détection précoce du CRC.
Mainz Biomed (NASDAQ:MYNZ) hat seinen ersten Patienten in die klinische Studie eAArly DETECT 2 aufgenommen, einen bedeutenden Meilenstein bei der Bewertung ihres Testverfahrens der nächsten Generation für Darmkrebs (CRC). Die Studie wird etwa 2.000 Patienten mit durchschnittlichem Risiko bewerten und kombiniert proprietäre mRNA-Biomarker, einen KI-entwickelten Algorithmus und einen FIT-Test.
Das Ziel der Studie ist es, frühere Machbarkeitsresultate zu validieren und den Übergang von CRC-Screening zu Prävention zu unterstützen. Die Einschreibung wird voraussichtlich in der zweiten Hälfte des Jahres 2025 abgeschlossen sein, mit geplanten Ergebnissen für das vierte Quartal 2025. Das Ergebnis wird helfen, die Protokolle für ReconAAsense, die entscheidende Studie des Unternehmens in den USA, die für 2026 geplant ist, abzuschließen.
Der Test umfasst fünf neuartige Biomarker für die Genexpression, die 2022 von der Universität Sherbrooke erworben wurden und die Fähigkeit gezeigt haben, sowohl fortgeschrittene Adenome (vorkrebsartige Dickdarmpolypen) als auch CRC im Frühstadium zu identifizieren. Die Studie zielt darauf ab, die diagnostische Sensitivität und Spezifität für die frühzeitige CRC-Erkennung zu verbessern.
- First patient enrolled in eAArly DETECT 2 study, advancing clinical development timeline
- Novel technology combines mRNA biomarkers, AI algorithm, and FIT test for enhanced detection
- Potential to prevent CRC through early detection of precancerous adenomas
- Study results will support progression to U.S. pivotal trial (ReconAAsense) in 2026
- Results not expected until Q4 2025, indicating long development timeline
- Success of the technology combination remains unproven in large-scale trials
Insights
Mainz Biomed's enrollment of the first patient in the eAArly DETECT 2 study represents a significant milestone in their clinical validation pathway for their next-generation colorectal cancer diagnostic. This 2,000-patient feasibility study specifically aims to validate the company's proprietary mRNA biomarkers combined with an AI algorithm and FIT testing - a technologically differentiated approach in the non-invasive CRC screening market.
What makes this diagnostic potentially disruptive is its focus on detecting advanced precancerous lesions (APL), effectively positioning it as a preventative tool rather than merely a screening one. The five novel gene expression biomarkers acquired from Sherbrooke University represent the core intellectual property driving this capability. If successful, this could shift the paradigm from cancer detection to cancer prevention.
The clear timeline guidance (enrollment completion in H2 2025, topline results in Q4 2025) provides a defined catalyst pathway, with the subsequent U.S. pivotal study (ReconAAsense) scheduled for 2026. For a microcap diagnostic company (
The technology differentiation here lies in targeting advanced adenomas - the precancerous lesions that, if detected and removed, could prevent colorectal cancer progression entirely. Most current non-invasive screening options are significantly less sensitive for these precursor lesions, focusing instead on detecting cancer after it has developed.
This first patient enrollment announcement signals Mainz Biomed's transition from preparation to execution phase in its clinical validation pathway. With a clear clinical timeline (enrollment completion in H2 2025 and results in Q4 2025), the company has established defined value-creating milestones that are crucial for microcap biotech companies to maintain investor interest.
Mainz's strategic positioning in the colorectal cancer screening market is notable. Rather than competing directly with established screening methods, they're targeting the significant clinical gap in non-invasive detection of advanced precancerous lesions. This prevention-focused approach could potentially command premium reimbursement if validated, as it addresses a higher-value clinical need than standard screening.
The company's technology combines multiple diagnostic modalities (mRNA biomarkers + AI algorithm + FIT) - a comprehensive approach that may deliver the sensitivity and specificity improvements needed to detect precancerous lesions effectively. Their previous acquisition of proprietary biomarkers from Sherbrooke University in 2022 appears to be the foundation of this differentiated approach.
For investors, this announcement confirms adherence to projected development timelines, which is particularly important for companies with capital resources. The progression to the pivotal ReconAAsense study in 2026 represents the key value inflection point ahead. With colorectal cancer remaining the second leading cause of cancer deaths despite being highly preventable when caught early, the market opportunity for improved early detection remains substantial.
2,000+ Average-Risk Patient Study Seeks to Confirm Mainz Biomed’s Industry-Leading Results in the Detection of Advanced Precancerous Lesions (APL) in Independent Samples
Study is on Track to Report Top-Line Results in Fourth Quarter 2025
BERKELEY, Calif., March 27, 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 the first patient has been enrolled in eAArly DETECT 2, a feasibility study to evaluate the Company’s next-generation colorectal cancer (CRC) test. The test integrates its proprietary mRNA biomarkers, an AI-developed algorithm, and a FIT test over a population of approximately 2,000 average-risk patients to validate the industry-leading results of previous feasibility studies and support the transition of CRC screening to CRC prevention.
The eAArly DETECT 2 study is expected to complete enrollment in the second half of 2025, and the Company targets reporting top-line results by the fourth quarter of 2025. Based on the study’s outcome, Mainz Biomed intends to finalize its protocols for ReconAAsense, the Company’s U.S. pivotal study, which is on track to initiate in 2026. This next-generation CRC and APL test will not only detect cancerous polyps with a high degree of accuracy but can potentially prevent the disease through early detection of precancerous adenomas.
“The first patient-in milestone marks the conclusion of several months of intensive preparatory work to ensure the trial is optimally managed and signifies the formal commencement of the study,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “This clinical trial is particularly exciting for the Company, the patient community, and the medical professionals alike. By precisely detecting advanced precancerous lesions and early-stage CRC, we aim to advance our mission of eliminating colorectal cancer and ultimately reducing global cancer mortality rates.”
The five novel gene expression (mRNA) biomarkers, which the Company acquired from Sherbrooke University in 2022, have demonstrated a unique ability to identify advanced adenomas – curable precancerous colonic polyps – as well as treatable early-stage CRC. The eAArly DETECT 2 study will further evaluate and confirm the effectiveness of these biomarkers combined with Mainz Biomed’s proprietary algorithm to enhance product specifications, extending its capability to include the identification of advanced adenomas while increasing rates of diagnostic sensitivity and specificity for early-stage CRC.
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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.
FAQ
What is the size and timeline of Mainz Biomed's (MYNZ) eAArly DETECT 2 study?
What technology does MYNZ's new colorectal cancer test combine?
When did MYNZ acquire the mRNA biomarkers used in the eAArly DETECT 2 study?
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