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Mainz Biomed and GANZIMMUN Announce Launch of Enhanced ColoAlert Colorectal Cancer Screening Ahead of Awareness Month

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Mainz Biomed (NASDAQ:MYNZ) and GANZIMMUN Diagnostics have launched an enhanced version of the ColoAlert colorectal cancer screening test across Germany, timing the release with March's Colorectal Cancer Awareness Month. The improved test, first introduced in mid-2024, features a proprietary DNA stabilizing buffer that ensures accurate results regardless of sample volume variations.

The launch coincides with Germany's updated national screening guidelines, which now provide equal access to colorectal cancer screening for both men and women starting at age 50, eliminating previous gender-based differences. This change follows research by the Institute for Quality and Efficiency in Health Care (IQWiG) that found no significant gender-based variations in recommended screening methods.

According to Tarrin Khairi-Taraki, VP Commercial Operations at Mainz Biomed, this development advances their mission of improving colorectal cancer prevention and detection. The collaborative effort between Mainz Biomed and GANZIMMUN demonstrates their commitment to enhancing cancer diagnostics through innovative solutions.

Mainz Biomed (NASDAQ:MYNZ) e GANZIMMUN Diagnostics hanno lanciato una versione migliorata del test di screening per il cancro colorettale ColoAlert in tutta Germania, sincronizzando il rilascio con il Mese della Consapevolezza sul Cancro Colorettale di marzo. Il test migliorato, introdotto per la prima volta a metà del 2024, presenta un buffer stabilizzante per il DNA proprietario che garantisce risultati accurati, indipendentemente dalle variazioni nel volume del campione.

Il lancio coincide con le nuove linee guida nazionali di screening della Germania, che ora offrono accesso equo allo screening del cancro colorettale per uomini e donne a partire dai 50 anni, eliminando le differenze di genere precedenti. Questo cambiamento segue una ricerca condotta dall'Istituto per la Qualità e l'Efficienza nelle Cure Sanitarie (IQWiG), che ha riscontrato l'assenza di variazioni significative basate sul genere nei metodi di screening raccomandati.

Secondo Tarrin Khairi-Taraki, VP delle Operazioni Commerciali di Mainz Biomed, questo sviluppo avanza la loro missione di migliorare la prevenzione e la rilevazione del cancro colorettale. L'iniziativa collaborativa tra Mainz Biomed e GANZIMMUN dimostra il loro impegno a potenziare la diagnostica oncologica attraverso soluzioni innovative.

Mainz Biomed (NASDAQ:MYNZ) y GANZIMMUN Diagnostics han lanzado una versión mejorada del test de detección de cáncer colorrectal ColoAlert en toda Alemania, sincronizando el lanzamiento con el Mes de Concienciación sobre el Cáncer Colorrectal de marzo. La prueba mejorada, introducida por primera vez a mediados de 2024, cuenta con un buffer estabilizante de ADN propietario que garantiza resultados precisos, independientemente de las variaciones en el volumen de muestra.

El lanzamiento coincide con las nuevas guías nacionales de detección de Alemania, que ahora ofrecen acceso equitativo a la detección del cáncer colorrectal tanto para hombres como para mujeres a partir de los 50 años, eliminando las diferencias de género anteriores. Este cambio sigue a una investigación del Instituto para la Calidad y la Eficiencia en la Atención Sanitaria (IQWiG) que no encontró variaciones significativas basadas en el género en los métodos de detección recomendados.

Según Tarrin Khairi-Taraki, VP de Operaciones Comerciales en Mainz Biomed, este desarrollo avanza su misión de mejorar la prevención y detección del cáncer colorrectal. El esfuerzo colaborativo entre Mainz Biomed y GANZIMMUN demuestra su compromiso de mejorar el diagnóstico del cáncer a través de soluciones innovadoras.

Mainz Biomed (NASDAQ:MYNZ)와 GANZIMMUN Diagnostics가 ColoAlert 대장암 스크리닝 테스트의 향상된 버전을 독일 전역에서 출시하며, 3월 대장암 인식의 달을 기념하고 있습니다. 2024년 중반 처음 소개된 개선된 테스트는 샘플 볼륨의 변동성에 관계없이 정확한 결과를 보장하는 고유의 DNA 안정화 버퍼를 특징으로 합니다.

이번 출시와 함께 독일의 새로운 국가 스크리닝 가이드라인이 시행되며, 이제 50세부터 남성과 여성 모두에게 대장암 스크리닝에 대한 동등한 접근을 제공합니다. 이는 권장되는 스크리닝 방법에서 성별에 따른 유의미한 차이가 없다는 것을 발견한 건강관리 품질 및 효율성 연구소(IQWiG)의 연구에 따른 변화입니다.

Mainz Biomed의 상업 운영 부사장인 Tarrin Khairi-Taraki에 따르면, 이러한 발전은 대장암 예방 및 조기 발견을 개선하려는 그들의 사명을 진전시키는 것입니다. Mainz Biomed와 GANZIMMUN 간의 협력 노력은 혁신적인 솔루션을 통해 암 진단을 향상시키려는 그들의 의지를 보여줍니다.

Mainz Biomed (NASDAQ:MYNZ) et GANZIMMUN Diagnostics ont lancé une version améliorée du test de dépistage du cancer colorectal ColoAlert à travers l'Allemagne, synchronisant le lancement avec le mois de sensibilisation au cancer colorectal de mars. Le test amélioré, introduit pour la première fois à la mi-2024, dispose d'un tampon stabilisant l'ADN propriétaire qui garantit des résultats précis, quelle que soit la variation du volume d'échantillon.

Ce lancement coïncide avec les nouvelles recommandations nationales de dépistage en Allemagne, qui désormais offrent un accès équitable au dépistage du cancer colorectal pour les hommes et les femmes à partir de 50 ans, éliminant les différences de genre précédentes. Ce changement fait suite à une recherche de l'Institut pour la Qualité et l'Efficacité dans le Système de Santé (IQWiG) qui n'a trouvé aucune variation significative basée sur le genre dans les méthodes de dépistage recommandées.

Selon Tarrin Khairi-Taraki, VP des Opérations Commerciales chez Mainz Biomed, ce développement fait avancer leur mission d'amélioration de la prévention et de la détection du cancer colorectal. L'effort collaboratif entre Mainz Biomed et GANZIMMUN démontre leur engagement à améliorer le diagnostic du cancer grâce à des solutions innovantes.

Mainz Biomed (NASDAQ:MYNZ) und GANZIMMUN Diagnostics haben eine verbesserte Version des ColoAlert-Krebsfrüherkennungstests in ganz Deutschland eingeführt und den Release mit dem Monat der Sensibilisierung für Darmkrebs im März abgestimmt. Der verbesserte Test, der erstmals Mitte 2024 eingeführt wurde, verfügt über einen proprietären DNA-stabilisierenden Puffer, der genaue Ergebnisse unabhängig von Abweichungen im Probenvolumen gewährleistet.

Der Launch fällt mit den aktualisierten nationalen Screening-Richtlinien in Deutschland zusammen, die nun einen gleichberechtigten Zugang zur Darmkrebsvorsorge für Männer und Frauen ab 50 Jahren bieten und vorherige geschlechtsspezifische Unterschiede beseitigen. Diese Änderung folgt einer Forschung des Instituts für Qualität und Effizienz im Gesundheitswesen (IQWiG), die keine signifikanten geschlechtsspezifischen Unterschiede in den empfohlenen Screening-Methoden festgestellt hat.

Laut Tarrin Khairi-Taraki, VP für kommerzielle Operationen bei Mainz Biomed, fördert diese Entwicklung ihre Mission zur Verbesserung der Prävention und Früherkennung von Darmkrebs. Die Zusammenarbeit zwischen Mainz Biomed und GANZIMMUN zeigt ihr Engagement für die Verbesserung der Krebsdiagnostik durch innovative Lösungen.

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Updated Screening Guidelines Ensure Broader Access to Colorectal Cancer Screening in Germany

BERKELEY, Calif. and MAINZ, Germany, Feb. 11, 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, is pleased to share that its partner, GANZIMMUN Diagnostics, has officially launched the enhanced ColoAlert colorectal cancer (CRC) screening test. Starting this January, patients across Germany can access this new version of the Company’s screening test, in time for Colorectal Cancer Awareness Month in March.

First introduced by Mainz Biomed in mid-2024, the enhanced ColoAlert features state-of-the-art advancements, including a proprietary DNA stabilizing buffer, to deliver accurate results even with varying sample volumes.

This collaborative launch reaffirms both companies’ shared dedication to advancing colorectal cancer prevention through innovation and accessibility. “This milestone brings us closer to our mission of improving colorectal cancer prevention and detection,” said Tarrin Khairi-Taraki, VP Commercial Operations at Mainz Biomed. “We are thrilled to support GANZIMMUN in making this pioneering test available to patients at such a critical time for cancer awareness.”

Boosting Awareness and Accessibility with Unified Screening Guidelines
The launch coincides with March Colorectal Cancer Awareness Month, a global initiative emphasizing the importance of early detection in fighting one of the most preventable cancers. This strategic timing highlights the critical role innovative diagnostics like ColoAlert play in saving lives.

Furthermore, the enhanced ColoAlert is launching at a time when awareness of colorectal cancer screening is increasing. Independently of this launch, Germany has recently updated its national screening program to ensure equal access for men and women starting at age 50, addressing prior gender-based discrepancies in risk assessment protocols. Research from the Institute for Quality and Efficiency in Health Care (IQWiG) found no notable differences in recommended screening methods or intervals by gender, paving the way for unified practices. By simplifying the screening process and promoting equal access, the updated guidelines are expected to drive broader participation and enhance the integration of preventive measures in healthcare settings.

The collaborative launch underscores the shared dedication of Mainz Biomed and GANZIMMUN to advancing colorectal cancer diagnostics through cutting-edge innovation. This advancement empowers laboratory partners to offer a superior screening solution that aligns perfectly with current healthcare demands and trends during a pivotal time in the fight against CRC.

Please visit Mainz Biomed’s official website for investors at mainzbiomed.com/investors/ for more information.

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About GANZIMMUN Diagnostics
GANZIMMUN Diagnostics is one of the leading laboratories in Europe for preventive and complementary medicine. A multidisciplinary team comprising more than 420 employees processes approximately 5,500 laboratory orders per day under the leadership of the experienced laboratory physician, Dr. med. Patrik Zickgraf. The comprehensive diagnostic service spectrum, which includes over 4,000 laboratory parameters, includes besides the basic analytics a huge amount of innovative tests such as the ColoAlert.
To learn more, visit https://www.ganzimmun.de/en/

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.

For media inquiries
MC Services AG
Anne Hennecke / Simone Neeten
+49 211 529252 20
mainzbiomed@mc-services.eu
For investor inquiries, please contact ir@mainzbiomed.com

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 improvements does the enhanced ColoAlert test by MYNZ offer in 2025?

The enhanced ColoAlert features a proprietary DNA stabilizing buffer that delivers accurate results regardless of sample volume variations, representing a significant advancement in colorectal cancer screening technology.

When did MYNZ launch the enhanced ColoAlert test in Germany?

The enhanced ColoAlert test was first introduced by Mainz Biomed in mid-2024, with the official launch through GANZIMMUN Diagnostics beginning in January 2025.

What are the new German screening guidelines for colorectal cancer in 2025?

The updated German guidelines now provide equal access to colorectal cancer screening for both men and women starting at age 50, removing previous gender-based differences in screening protocols.

How does the MYNZ ColoAlert launch align with cancer awareness initiatives?

The enhanced ColoAlert launch is strategically timed with March's Colorectal Cancer Awareness Month, emphasizing the importance of early detection in fighting one of the most preventable cancers.

What is the significance of MYNZ's partnership with GANZIMMUN for colorectal cancer screening?

The partnership enables broader access to advanced colorectal cancer screening across Germany, combining MYNZ's innovative technology with GANZIMMUN's distribution capabilities to improve cancer prevention efforts.

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