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Mainz Biomed Launches Enhanced ColoAlert with Cutting-Edge Features to Optimize Screening Efficiency and User Convenience

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Mainz Biomed N.V. (NASDAQ: MYNZ) has announced significant improvements to its ColoAlert product, a highly efficacious at-home detection test for colorectal cancer (CRC). The enhancements include:

1. A novel DNA stabilizing buffer that accommodates varying sample volumes, reducing the need for retesting and enabling results delivery within 2-3 days.

2. Refined kit features for improved usability, including an enhanced collection device and new tube design.

These upgrades aim to enhance customer satisfaction, streamline lab operations, and maintain ColoAlert's position as a leading CRC screening solution. The improved product is now available to existing and prospective laboratory partners.

Mainz Biomed N.V. (NASDAQ: MYNZ) ha annunciato significativi miglioramenti al suo prodotto ColoAlert, un test di rilevamento altamente efficace per il cancro colorettale (CRC) da effettuare a casa. I miglioramenti includono:

1. Un nuovo tampone stabilizzante del DNA che consente di gestire volumi di campione variabili, riducendo la necessità di rifacimenti e consentendo la consegna dei risultati entro 2-3 giorni.

2. Caratteristiche del kit migliorate per una maggiore facilità d'uso, inclusi un dispositivo di raccolta potenziato e un nuovo design del tubo.

Questi aggiornamenti mirano a migliorare la soddisfazione del cliente, semplificare le operazioni di laboratorio e mantenere la posizione di ColoAlert come soluzione leader nello screening del CRC. Il prodotto migliorato è ora disponibile per i partner di laboratorio esistenti e potenziali.

Mainz Biomed N.V. (NASDAQ: MYNZ) ha anunciado mejoras significativas en su producto ColoAlert, una prueba de detección altamente eficaz para el cáncer colorrectal (CRC) que se realiza en casa. Las mejoras incluyen:

1. Un innovador tampón estabilizador de ADN que se adapta a diferentes volúmenes de muestra, reduciendo la necesidad de repetir pruebas y permitiendo la entrega de resultados en 2-3 días.

2. Características del kit refinadas para mejorar la usabilidad, incluyendo un dispositivo de recolección mejorado y un nuevo diseño de tubo.

Estas mejoras tienen como objetivo aumentar la satisfacción del cliente, optimizar las operaciones del laboratorio y mantener la posición de ColoAlert como una solución líder en el screening del CRC. El producto mejorado está ahora disponible para socios de laboratorio existentes y potenciales.

Mainz Biomed N.V. (NASDAQ: MYNZ)는 자택에서 사용할 수 있는 고효율 대장암 (CRC) 검출 테스트인 ColoAlert 제품에 대한 주요 개선사항을 발표했습니다. 개선사항은 다음과 같습니다:

1. 다양한 샘플 용적을 수용할 수 있는 새로운 DNA 안정화 완충액으로, 재검사 필요성을 줄이고 2-3일 이내에 결과를 전달할 수 있습니다.

2. 향상된 수집 장치와 새로운 튜브 디자인을 포함한 사용성을 개선한 키트 기능.

이러한 업그레이드는 고객 만족도를 높이고 실험실 운영을 간소화하며 ColoAlert가 CRC 선별 검사 솔루션으로서의 위치를 유지하는 것을 목표로 하고 있습니다. 개선된 제품은 기존 및 잠재적인 실험실 파트너에게 제공됩니다.

Mainz Biomed N.V. (NASDAQ: MYNZ) a annoncé des améliorations significatives de son produit ColoAlert, un test de détection hautement efficace pour le cancer colorectal (CRC) à domicile. Les améliorations comprennent :

1. Un nouveau tampon stabilisant l'ADN qui s'adapte à différents volumes d'échantillon, réduisant ainsi la nécessité de tests répétés et permettant la livraison des résultats dans un délai de 2 à 3 jours.

2. Fonctionnalités du kit affinées pour une meilleure convivialité, y compris un dispositif de collecte amélioré et un nouveau design de tube.

Ces améliorations visent à accroître la satisfaction des clients, à rationaliser les opérations de laboratoire et à maintenir la position de ColoAlert en tant que solution de dépistage CRC de premier plan. Le produit amélioré est désormais disponible pour les partenaires de laboratoire existants et potentiels.

Mainz Biomed N.V. (NASDAQ: MYNZ) hat bedeutende Verbesserungen seines Produkts ColoAlert angekündigt, einem hochwirksamen Heimtest zur Früherkennung von Darmkrebs (CRC). Zu den Verbesserungen gehören:

1. Ein neuartiger DNA-stabilisierender Puffer, der unterschiedliche Probenvolumina berücksichtigt, wodurch die Notwendigkeit von Nachtests verringert wird und die Ergebnisse innerhalb von 2-3 Tagen bereitgestellt werden können.

2. Verfeinerte Kit-Funktionen für eine verbesserte Benutzerfreundlichkeit, einschließlich eines optimierten Entnahmegeräts und einem neuen Röhrendesign.

Diese Verbesserungen sollen die Kundenzufriedenheit erhöhen, die Laborabläufe optimieren und die Position von ColoAlert als führende CRC-Screening-Lösung stärken. Das verbesserte Produkt ist nun für bestehende und potenzielle Laborpartner verfügbar.

Positive
  • Introduction of a novel DNA stabilizing buffer that reduces retesting rates
  • Faster result delivery within 2-3 days upon sample arrival at the laboratory
  • Improved usability of the ColoAlert kit with new features for easier sample collection
  • Expansion of product availability to existing and new laboratory partners
Negative
  • None.

Insights

Mainz Biomed's enhancements to ColoAlert represent a significant leap forward in colorectal cancer (CRC) screening technology. The introduction of a novel DNA stabilizing buffer is particularly noteworthy, as it addresses a critical issue in sample collection. By accommodating varying sample volumes, this innovation could dramatically reduce retesting rates, a common bottleneck in CRC screening programs.

From a medical research perspective, the ability to preserve DNA samples more effectively is crucial. It ensures higher quality genetic material for analysis, potentially leading to more accurate results and fewer false negatives or positives. The reported 2-3 day turnaround time for results is impressively quick, which could lead to earlier detection and intervention in CRC cases.

However, it's important to note that while these improvements enhance usability and efficiency, they don't necessarily increase the test's sensitivity or specificity for detecting CRC. Future studies comparing the enhanced ColoAlert to gold standard screening methods like colonoscopy will be important to validate its clinical effectiveness.

Overall, these upgrades position ColoAlert as a more competitive option in the growing market for non-invasive CRC screening tools, potentially increasing its adoption rate among healthcare providers and patients alike.

Mainz Biomed's product enhancements for ColoAlert demonstrate a strategic move to differentiate in the competitive colorectal cancer screening market. The focus on improving user experience and laboratory efficiency addresses key pain points in the screening process, which could lead to increased market share.

The reduction in retesting rates is particularly significant from a market perspective. It not only improves patient satisfaction but also reduces costs for laboratories, making ColoAlert a more attractive option for healthcare providers. This could potentially lead to broader adoption and increased sales volume.

Moreover, the emphasis on rapid turnaround time (2-3 days) aligns with the growing demand for quick and convenient healthcare solutions. In a market where patient experience is increasingly important, this feature could be a strong selling point.

However, it's worth noting that Mainz Biomed is operating in a highly competitive space, with established players like Exact Sciences' Cologuard. The company will need to leverage these improvements in their marketing strategy to effectively differentiate ColoAlert and gain market traction.

While these enhancements are promising, investors should monitor how they translate into tangible market gains, such as increased partnerships with laboratories and higher test volumes, in the coming quarters.

BERKELEY, Calif. and MAINZ, Germany, July 25, 2024 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQ: MYNZ), a molecular genetics diagnostic company specializing in early detection of cancer, today announced significant improvements to its ColoAlert product, currently being commercialized across Europe and in select international markets. These updates aim to enhance customer satisfaction and streamline lab operations.

ColoAlert is a highly efficacious and easy-to-use, at-home detection test for colorectal cancer (CRC). The test utilizes proprietary methods to analyze cell DNA for specific tumor markers combined with the fecal immunochemical test (FIT). It is designed to detect tumor DNA and CRC cases in their earliest stages.

To increase screening/lab efficiency, Mainz Biomed has introduced a novel DNA stabilizing buffer capable of accommodating varying sample volumes. This breakthrough addresses a common issue in the industry where samples are often either underfilled or overfilled, rendering them unsuitable for laboratory analysis. Consequently, patients frequently have to repeat their screening test. The new proprietary buffer used in ColoAlert significantly reduces the necessity for additional sample submissions, thereby reducing the time for the patients to obtain their results. This enhancement has enabled ColoAlert to achieve the industry's lowest retesting rates, ensuring that screening outcomes are delivered within just 2 - 3 days upon arrival at the laboratory.

Furthermore, Mainz Biomed has refined the ColoAlert kit for improved usability, including a variety of new features, such as an improved collection device, a new tube and tube holder, etc. These upgrades streamline the sample collection process, offering users a more straightforward and reliable experience.

"Our commitment to preserving DNA samples and optimizing testing procedures underscores our dedication to delivering superior colorectal cancer screening while ensuring convenience for patients," stated Tarrin Khairi-Taraki, VP Commercial Operations at Mainz Biomed.

The updated ColoAlert product is now accessible to existing laboratory partners and readily available to prospective collaborators.

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

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About Colorectal Cancer
Colorectal cancer (CRC) is the third most common cancer globally, with more than 1.9 million new cases reported in 2020, according to World Cancer Research Fund International. The US Preventive Services Task Force recommends that screening with stool DNA tests such as ColoAlert® should be conducted once every three years starting at age 45. Each year in the US, 16.6 million colonoscopies are performed. However, roughly one-third of US residents aged 50-75 have never been screened for colon cancer. This gap in screening represents a $4.0B+ total market opportunity in the US.

About Mainz Biomed N.V.  
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 based on real-time Polymerase Chain Reaction-based (PCR) multiplex detection of molecular-genetic biomarkers in stool samples. ColoAlert® is currently marketed across Europe. The Company is planning to run 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. To learn more, visit mainzbiomed.com.   

For media inquiries

MC Services AG
Anne Hennecke/Caroline Bergmann
+49 211 529252 20
mainzbiomed@mc-services.eu

For investor inquiries, please contact info@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 has Mainz Biomed (MYNZ) made to its ColoAlert product?

Mainz Biomed has introduced a novel DNA stabilizing buffer that reduces retesting rates and enables faster results delivery. They have also improved the usability of the ColoAlert kit with new features for easier sample collection.

How long does it take to get ColoAlert test results from Mainz Biomed (MYNZ)?

With the new improvements, ColoAlert test results are delivered within 2-3 days upon arrival of the sample at the laboratory.

What is the main benefit of the new DNA stabilizing buffer in Mainz Biomed's (MYNZ) ColoAlert?

The new DNA stabilizing buffer accommodates varying sample volumes, significantly reducing the need for additional sample submissions and lowering retesting rates.

When will the improved ColoAlert product from Mainz Biomed (MYNZ) be available?

The updated ColoAlert product is now accessible to existing laboratory partners and readily available to prospective collaborators.

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