Mainz Biomed Initiates U.S. Clinical Study to Evaluate Performance of Next Generation Test on Advanced Adenomas over Large Patient Population
Mainz Biomed (NASDAQ:MYNZ) has launched eAArly DETECT 2, a U.S. feasibility study to evaluate its next-generation colorectal cancer (CRC) test. The study will assess the performance of the company's proprietary mRNA biomarkers, AI-developed algorithm, and FIT test across approximately 2,000 average-risk patients.
The study aims to validate previous promising results and is expected to complete enrollment in the second half of 2025, with topline results targeted for Q4 2025. Following this study, Mainz Biomed plans to finalize protocols for ReconAAsense, their U.S. pivotal study scheduled for 2026.
The next-generation test incorporates five novel gene expression biomarkers acquired from Sherbrooke University in 2022, designed to detect both advanced adenomas (precancerous polyps) and early-stage CRC with high accuracy.
Mainz Biomed (NASDAQ:MYNZ) ha avviato eAArly DETECT 2, uno studio di fattibilità negli Stati Uniti per valutare il suo test di nuova generazione per il cancro colorettale (CRC). Lo studio valuterà le prestazioni dei biomarcatori mRNA proprietari dell'azienda, dell'algoritmo sviluppato dall'IA e del test FIT su circa 2.000 pazienti a rischio medio.
Lo studio mira a convalidare i precedenti risultati promettenti e si prevede che completerà l'arruolamento nella seconda metà del 2025, con risultati preliminari previsti per il Q4 2025. Dopo questo studio, Mainz Biomed pianifica di finalizzare i protocolli per ReconAAsense, il loro studio cruciale negli Stati Uniti programmato per il 2026.
Il test di nuova generazione incorpora cinque biomarcatori di espressione genica innovativi acquisiti dall'Università di Sherbrooke nel 2022, progettati per rilevare sia adenomi avanzati (polipi precoci) sia CRC in fase iniziale con alta precisione.
Mainz Biomed (NASDAQ:MYNZ) ha lanzado eAArly DETECT 2, un estudio de viabilidad en EE. UU. para evaluar su prueba de nueva generación para el cáncer colorrectal (CRC). El estudio evaluará el rendimiento de los biomarcadores de mRNA propietarias de la compañía, del algoritmo desarrollado por IA y de la prueba FIT en aproximadamente 2,000 pacientes de riesgo promedio.
El estudio tiene como objetivo validar resultados anteriores prometedores y se espera que complete la inscripción en la segunda mitad de 2025, con resultados preliminares dirigidos para el cuarto trimestre de 2025. Tras este estudio, Mainz Biomed planea finalizar los protocolos para ReconAAsense, su estudio pivotal en EE. UU. programado para 2026.
La prueba de nueva generación incorpora cinco biomarcadores de expresión génica novedosos adquiridos de la Universidad de Sherbrooke en 2022, diseñados para detectar tanto adenomas avanzados (pólipos precoces) como CRC en etapas tempranas con alta precisión.
Mainz Biomed (NASDAQ:MYNZ)는 차세대 대장암(CRC) 검사를 평가하기 위해 미국에서 eAArly DETECT 2라는 타당성 연구를 시작했습니다. 이 연구는 회사의 독점 mRNA 바이오마커, AI 개발 알고리즘 및 FIT 테스트의 성능을 약 2,000명의 평균 위험 환자를 대상으로 평가할 것입니다.
이 연구는 이전의 유망한 결과를 검증하는 것을 목표로 하며, 2025년 하반기에 등록을 완료할 것으로 예상되며, 2025년 4분기에 주요 결과를 발표할 예정입니다. 이 연구 후 Mainz Biomed는 2026년으로 예정된 미국의 주요 연구인 ReconAAsense를 위한 프로토콜을 최종 확정할 계획입니다.
차세대 검사는 2022년에 셔브룩대학교에서 획득한 다섯 개의 새로운 유전자 발현 바이오마커를 포함하여, 고도의 정확도로 진행성 선종(전암성 폴립) 및 초기 단계 CRC를 모두 검출하도록 설계되었습니다.
Mainz Biomed (NASDAQ:MYNZ) a lancé eAArly DETECT 2, une étude de faisabilité aux États-Unis pour évaluer son test de nouvelle génération pour le cancer colorectal (CRC). L'étude évaluera la performance de ses biomarqueurs d'ARNm propriétaires, de son algorithme développé par IA et du test FIT sur environ 2 000 patients à risque moyen.
L'étude vise à valider des résultats prometteurs antérieurs et devrait achever l'inscription dans la seconde moitié de 2025, avec des résultats préliminaires attendus pour le T4 2025. Suite à cette étude, Mainz Biomed prévoit de finaliser les protocoles pour ReconAAsense, leur étude pivot prévue aux États-Unis pour 2026.
Le test de nouvelle génération intègre cinq biomarqueurs d'expression génétiques novateurs acquis de l'Université de Sherbrooke en 2022, conçus pour détecter à la fois les adénomes avancés (polypes précoces) et le CRC à un stade précoce avec une grande précision.
Mainz Biomed (NASDAQ:MYNZ) hat eAArly DETECT 2 gestartet, eine Machbarkeitsstudie in den USA zur Bewertung seines Tests der nächsten Generation für Darmkrebs (CRC). Die Studie wird die Leistung der firmeneigenen mRNA-Biomarker, des KI-entwickelten Algorithmus und des FIT-Tests bei ungefähr 2.000 Patienten mit durchschnittlichem Risiko bewerten.
Ziel der Studie ist es, frühere vielversprechende Ergebnisse zu validieren, und es wird erwartet, dass die Einschreibung in der zweiten Hälfte des Jahres 2025 abgeschlossen ist, mit vorläufigen Ergebnissen, die für das 4. Quartal 2025 angestrebt werden. Nach dieser Studie plant Mainz Biomed, die Protokolle für ReconAAsense, ihre bahnbrechende Studie in den USA, die für 2026 angesetzt ist, abzuschließen.
Der Test der nächsten Generation umfasst fünf neuartige Geneexpressions-Biomarker, die 2022 von der Universität Sherbrooke erworben wurden und entwickelt wurden, um sowohl fortgeschrittene Adenome (vorkrebse Polypen) als auch Frühstadien von CRC mit hoher Genauigkeit zu erkennen.
- Launch of large-scale feasibility study (2,000 patients) for next-generation CRC test
- Integration of proprietary mRNA biomarkers and AI algorithm for enhanced detection capabilities
- Potential to detect both cancerous and pre-cancerous polyps, enabling early intervention
- Clear timeline for study completion (Q4 2025) and subsequent pivotal study (2026)
- Results and commercial viability won't be known until Q4 2025
- Success of previous feasibility studies needs validation in larger population
- Pivotal study timeline extends commercialization horizon to 2026 and beyond
Insights
The initiation of eAArly DETECT 2 represents a pivotal development in colorectal cancer (CRC) screening technology. The study's focus on a 2,000-patient cohort provides statistical power to validate the mRNA biomarker performance specifically for advanced adenomas detection. The combination of proprietary mRNA biomarkers, AI algorithms and FIT testing creates a comprehensive screening approach that could revolutionize early detection capabilities.
The integration of advanced adenoma detection is particularly noteworthy - while current screening methods primarily focus on detecting existing cancers, this next-generation test aims to identify precancerous polyps, potentially preventing CRC development altogether. Success here would represent a paradigm shift from cancer detection to cancer prevention.
The timeline targeting completion in Q4 2025 aligns with industry standards for clinical validation studies of this scale. This positions ReconAAsense, the pivotal study planned for 2026, to potentially accelerate FDA approval pathways if positive results emerge.
From a market perspective, this development carries substantial commercial implications. The global CRC screening market, valued at approximately
The study's focus on average-risk patients is strategically important - this represents the largest market segment for CRC screening. Success in this population would position Mainz Biomed to compete directly with established players in the routine screening market, rather than being to high-risk populations.
Given MYNZ's current market cap of
eAArly DETECT 2 feasibility study designed to validate earlier results on advanced adenomas over a large population of average risk patients
Multi-center study expected to complete enrollment in the second half and reporting in the Fourth Quarter of 2025
BERKELEY, Calif. and MAINZ, Germany, Jan. 21, 2025 (GLOBE NEWSWIRE) -- Mainz Biomed NV (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today the launch of eAArly DETECT 2, a U.S. feasibility study to evaluate the Company’s next generation colorectal cancer (CRC) test, integrating its proprietary mRNA biomarkers, AI developed algorithm and FIT test, over a population of approximately 2,000 patients, all of average risk, to validate the industry leading results of previous feasibility studies, which included average risk and identified risk patients.
The eAArly DETECT 2 study is expected to complete enrollment in the second half of 2025 and the Company targets reporting topline 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 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 launch of eAArly DETECT 2 is an important milestone for the Company as it enables us to accelerate the timeline to evaluate the potential of these biomarkers to be incorporated into our U.S. pivotal study, which is on track to initiate in 2026,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “The potential inclusion of advanced adenomas in Mainz BioMed’s next generation CRC screening test will represent a transformational advancement in self-administered CRC screening. Precise detection of advanced adenomas as well as early-stage CRC supports our mission to transform colorectal cancer screening practices and reduce global cancer mortality rates.”
The five novel gene expression (mRNA) biomarkers, which the Company acquired from the Sherbrooke University in 2022, have demonstrated a unique ability to identify advanced adenomas, i.e. 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 AI algorithm to enhance product specifications to extend 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 and the United Arab Emirates. 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. 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.
FAQ
What is the expected timeline for Mainz Biomed's eAArly DETECT 2 study results?
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What makes Mainz Biomed's CRC screening test different from existing tests?
