Mainz Biomed Announces Interim Read Out For Its eAArly DETECT 2 Clinical Study
Mainz Biomed (NASDAQ:MYNZ) announced plans to provide an interim read out of its eAArly DETECT 2 feasibility study by the end of summer 2025, with top-line results expected in Q4 2025. The study evaluates the company's next-generation colorectal cancer (CRC) screening test across approximately 2,000 average-risk patients.
The test combines proprietary mRNA biomarkers, an AI-developed algorithm, and a FIT test to detect both cancerous polyps and precancerous adenomas. Based on the study's outcome, Mainz Biomed plans to finalize protocols for ReconAAsense, its U.S. pivotal study, scheduled to begin in 2026.
The company's five novel gene expression biomarkers, acquired from Sherbrooke University in 2022, have shown capability in identifying advanced adenomas and early-stage CRC, potentially advancing CRC screening to prevention.
Mainz Biomed (NASDAQ:MYNZ) ha annunciato l'intenzione di fornire una lettura preliminare del suo studio di fattibilità eAArly DETECT 2 entro la fine dell'estate 2025, con i risultati principali attesi nel quarto trimestre del 2025. Lo studio valuta il test di screening per il cancro del colon-retto (CRC) di nuova generazione dell'azienda su circa 2.000 pazienti a rischio medio.
Il test combina biomarcatori proprietari di mRNA, un algoritmo sviluppato con intelligenza artificiale e un test FIT per rilevare sia i polipi cancerosi che gli adenomi precancerosi. In base ai risultati dello studio, Mainz Biomed prevede di finalizzare i protocolli per ReconAAsense, il suo studio cardine negli Stati Uniti, programmato per iniziare nel 2026.
I cinque nuovi biomarcatori di espressione genica dell'azienda, acquisiti dall'Università di Sherbrooke nel 2022, hanno dimostrato la capacità di identificare adenomi avanzati e CRC in fase precoce, aprendo potenzialmente la strada a uno screening del CRC orientato alla prevenzione.
Mainz Biomed (NASDAQ:MYNZ) anunció planes para proporcionar un informe provisional de su estudio de viabilidad eAArly DETECT 2 para finales del verano de 2025, con resultados principales esperados en el cuarto trimestre de 2025. El estudio evalúa la prueba de detección de cáncer colorrectal (CRC) de próxima generación de la compañía en aproximadamente 2,000 pacientes de riesgo promedio.
La prueba combina biomarcadores de ARNm patentados, un algoritmo desarrollado con IA y una prueba FIT para detectar tanto pólipos cancerosos como adenomas precancerosos. Según el resultado del estudio, Mainz Biomed planea finalizar los protocolos para ReconAAsense, su estudio pivotal en EE. UU., programado para comenzar en 2026.
Los cinco nuevos biomarcadores de expresión génica de la compañía, adquiridos de la Universidad de Sherbrooke en 2022, han demostrado capacidad para identificar adenomas avanzados y CRC en etapa temprana, lo que podría avanzar la detección del CRC hacia la prevención.
Mainz Biomed (NASDAQ:MYNZ)는 2025년 여름 말까지 eAArly DETECT 2 타당성 연구의 중간 결과를 제공할 계획이며, 주요 결과는 2025년 4분기에 발표될 예정이라고 발표했습니다. 이 연구는 약 2,000명의 평균 위험군 환자를 대상으로 회사의 차세대 대장암(CRC) 선별 검사를 평가합니다.
이 검사는 독자적인 mRNA 바이오마커, AI로 개발된 알고리즘, FIT 검사를 결합하여 암성 용종과 전암성 선종 모두를 탐지합니다. 연구 결과를 바탕으로 Mainz Biomed는 2026년에 시작될 예정인 미국 중추 연구인 ReconAAsense의 프로토콜을 최종 확정할 계획입니다.
회사가 2022년 셔브룩 대학교에서 인수한 다섯 가지 새로운 유전자 발현 바이오마커는 진행된 선종과 초기 단계 CRC를 식별하는 능력을 보여주었으며, CRC 선별을 예방 단계로 발전시킬 잠재력을 가지고 있습니다.
Mainz Biomed (NASDAQ:MYNZ) a annoncé son intention de fournir un premier compte rendu de son étude de faisabilité eAArly DETECT 2 d'ici la fin de l'été 2025, avec des résultats principaux attendus au quatrième trimestre 2025. L'étude évalue le test de dépistage du cancer colorectal (CRC) de nouvelle génération de la société sur environ 2 000 patients à risque moyen.
Le test combine des biomarqueurs d'ARNm propriétaires, un algorithme développé par IA et un test FIT pour détecter à la fois les polypes cancéreux et les adénomes précancéreux. En fonction des résultats de l'étude, Mainz Biomed prévoit de finaliser les protocoles pour ReconAAsense, son étude pivot aux États-Unis, prévue pour débuter en 2026.
Les cinq nouveaux biomarqueurs d'expression génique de la société, acquis auprès de l'Université de Sherbrooke en 2022, ont démontré leur capacité à identifier les adénomes avancés et le CRC à un stade précoce, ouvrant potentiellement la voie à un dépistage du CRC axé sur la prévention.
Mainz Biomed (NASDAQ:MYNZ) kündigte Pläne an, bis Ende Sommer 2025 eine vorläufige Auswertung seiner eAArly DETECT 2 Machbarkeitsstudie bereitzustellen, wobei die wichtigsten Ergebnisse im vierten Quartal 2025 erwartet werden. Die Studie bewertet den neuen Darmkrebsvorsorgetest (CRC) des Unternehmens bei etwa 2.000 Patienten mit durchschnittlichem Risiko.
Der Test kombiniert firmeneigene mRNA-Biomarker, einen KI-entwickelten Algorithmus und einen FIT-Test, um sowohl krebsartige Polypen als auch präkanzeröse Adenome zu erkennen. Basierend auf den Studienergebnissen plant Mainz Biomed, die Protokolle für ReconAAsense, seine entscheidende US-Studie, die 2026 starten soll, abzuschließen.
Die fünf neuartigen Genexpressions-Biomarker des Unternehmens, die 2022 von der Universität Sherbrooke erworben wurden, haben gezeigt, dass sie fortgeschrittene Adenome und frühstadiale CRC identifizieren können, was die Darmkrebsvorsorge möglicherweise in Richtung Prävention voranbringt.
- Integration of novel mRNA biomarkers with AI algorithm shows promise for early cancer detection
- Study aims to validate previous feasibility studies' industry-leading results
- Technology could advance from CRC screening to prevention through early adenoma detection
- On track for U.S. pivotal trial initiation in 2026
- Results from the current study not yet available
- U.S. pivotal trial still pending and subject to successful completion of current study
Insights
Mainz Biomed's CRC test study progressing well, aiming for clinical validation of novel biomarkers to potentially transform colorectal cancer screening to prevention.
Mainz Biomed's announcement provides an important update on the timeline for their eAArly DETECT 2 feasibility study evaluating their next-generation colorectal cancer (CRC) screening test. The company has set clear expectations for an interim readout by the end of summer 2025, with top-line results targeted for Q4 2025. This 2,000-patient study represents a critical step toward their U.S. pivotal trial (ReconAAsense) scheduled for 2026.
What makes this particular test scientifically significant is its integration of proprietary mRNA biomarkers with an AI-developed algorithm and a FIT (Fecal Immunochemical Test). The five novel gene expression biomarkers, acquired from Sherbrooke University in 2022, have shown promise in identifying advanced adenomas - precancerous polyps that are still curable - as well as early-stage colorectal cancer when treatment is most effective.
This study is particularly noteworthy as it aims to shift the paradigm from merely screening for cancer to actually preventing it through early detection of precancerous lesions. The potential clinical utility is substantial, as removing precancerous adenomas can effectively prevent cancer development altogether.
The company appears to be executing according to its clinical development timeline, which reduces operational risk. The announcement of an interim readout suggests confidence in their progress, though investors should note that no preliminary efficacy data was disclosed in this release.
If successful, this technology could represent a meaningful advance in non-invasive CRC screening, potentially improving upon current methods that have limitations in detecting precancerous lesions. The commercial implications would be significant in the multi-billion dollar colorectal cancer screening market, where early detection translates to better survival rates and lower treatment costs.
Company intends to provide an interim read out by the end of summer 2025
Top-line results anticipated in Q4 2025; study on track to support U.S. pivotal trial initiation in 2026
BERKELEY, Calif. and MAINZ, Germany, May 16, 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 that it intends to provide an interim read out of its eAArly DETECT 2 feasibility study by the end of summer 2025. The study is evaluating the Company’s next-generation colorectal cancer (CRC) screening test that integrates Mainz Biomeds 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 (Adenomatous Polyps) 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.
“We are excited about the progress the team has been making on eAArly DETECT 2 and look forward to providing partners and shareholders an interim update, targeted for the end of this summer,” 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 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 in 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. These forward-looking statements include information concerning possible or projected future results of our operations, including statements about our clinical trials and studies, business strategies or plans; prospects; future cash flows; financing plans; objectives of management; future cash needs; and any other statements that are not historical facts. 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. 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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