Mainz Biomed Announces Registration of ColoAlert in the United Kingdom
Mainz Biomed (NASDAQ:MYNZ) has achieved a significant milestone with the registration of ColoAlert®, its DNA-based colorectal cancer screening test, by the UK's Medicines and Healthcare products Regulatory Agency (MHRA). This regulatory approval enables marketing authorization across the United Kingdom.
The registration follows Mainz's technology partnership with EDX Medical Group plc and aims to address the UK's colorectal cancer burden, where approximately 44,000 new cases are diagnosed annually. ColoAlert will complement the existing Bowel Cancer Screening Program, which currently serves people aged 50-74, by providing a non-invasive screening option that detects DNA biomarkers in stool samples.
Mainz Biomed (NASDAQ:MYNZ) ha raggiunto un traguardo importante: il test di screening del cancro colorettale basato sul DNA, ColoAlert®, è stato registrato presso la Medicines and Healthcare products Regulatory Agency (MHRA) del Regno Unito. Questa approvazione normativa consente l'autorizzazione alla commercializzazione in tutto il Regno Unito.
La registrazione segue la partnership tecnologica di Mainz con EDX Medical Group plc e si propone di contribuire ad affrontare l'onere del cancro colorettale nel Regno Unito, dove ogni anno vengono diagnosticati circa 44.000 nuovi casi. ColoAlert integrerà l'attuale Bowel Cancer Screening Program, rivolto alle persone di età compresa tra 50 e 74 anni, offrendo un'opzione di screening non invasiva che rileva biomarcatori del DNA nelle feci.
Mainz Biomed (NASDAQ:MYNZ) ha alcanzado un hito importante: su prueba de cribado del cáncer colorrectal basada en ADN, ColoAlert®, ha sido registrada por la Medicines and Healthcare products Regulatory Agency (MHRA) del Reino Unido. Esta aprobación regulatoria permite la autorización de comercialización en todo el Reino Unido.
La inscripción se produce tras la alianza tecnológica de Mainz con EDX Medical Group plc y pretende ayudar a reducir la carga del cáncer colorrectal en el Reino Unido, donde se diagnostican aproximadamente 44.000 nuevos casos al año. ColoAlert complementará el actual Bowel Cancer Screening Program, dirigido a personas de 50 a 74 años, ofreciendo una opción de cribado no invasiva que detecta biomarcadores de ADN en muestras de heces.
Mainz Biomed (NASDAQ:MYNZ)는 DNA 기반 대장암 검사인 ColoAlert®의 영국 의약품규제기관(MHRA) 등록을 통해 중요한 이정표를 달성했습니다. 이 규제 승인으로 영국 전역에서 시판허가를 받을 수 있게 되었습니다.
이번 등록은 Mainz의 EDX Medical Group plc와의 기술 제휴에 따른 것으로, 연간 약 44,000건의 신규 진단이 발생하는 영국의 대장암 문제를 해결하는 데 목적이 있습니다. ColoAlert은 현재 50~74세를 대상으로 하는 Bowel Cancer Screening Program을 보완하며, 대변 샘플에서 DNA 바이오마커를 검출하는 비침습적 선별 옵션을 제공합니다.
Mainz Biomed (NASDAQ:MYNZ) a franchi une étape importante : son test de dépistage du cancer colorectal basé sur l'ADN, ColoAlert®, a été enregistré auprès de la Medicines and Healthcare products Regulatory Agency (MHRA) du Royaume-Uni. Cette approbation réglementaire permet l'autorisation de mise sur le marché sur l'ensemble du territoire britannique.
Cette enregistrement fait suite au partenariat technologique de Mainz avec EDX Medical Group plc et vise à répondre au fardeau du cancer colorectal au Royaume-Uni, où environ 44 000 nouveaux cas sont diagnostiqués chaque année. ColoAlert viendra compléter le Bowel Cancer Screening Program existant, qui couvre actuellement les personnes de 50 à 74 ans, en proposant une option de dépistage non invasive détectant des biomarqueurs d'ADN dans les selles.
Mainz Biomed (NASDAQ:MYNZ) hat einen wichtigen Meilenstein erreicht: Der DNA-basierte Darmkrebs-Screening-Test ColoAlert® wurde bei der britischen Medicines and Healthcare products Regulatory Agency (MHRA) registriert. Diese behördliche Genehmigung ermöglicht die Marktzulassung im gesamten Vereinigten Königreich.
Die Registrierung folgt auf die Technologopartnerschaft von Mainz mit EDX Medical Group plc und zielt darauf ab, die Belastung durch Darmkrebs im Vereinigten Königreich anzugehen, wo jährlich etwa 44.000 neue Fälle diagnostiziert werden. ColoAlert wird das bestehende Bowel Cancer Screening Program, das derzeit Personen im Alter von 50 bis 74 Jahren abdeckt, ergänzen und eine nicht-invasive Screening-Option bieten, die DNA-Biomarker in Stuhlproben nachweist.
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Insights
Mainz Biomed's ColoAlert UK approval opens a significant market of 44,000 annual colorectal cancer cases, complementing existing screening programs.
Mainz Biomed has achieved a critical regulatory milestone with MHRA registration for ColoAlert in the United Kingdom, enabling commercialization in one of Europe's key healthcare markets. This non-invasive, DNA-based colorectal cancer screening test now has access to a substantial patient population, with the UK reporting approximately 44,000 new colorectal cancer cases annually.
The approval represents the successful execution of Mainz's market access strategy following their technology partnership with EDX Medical Group, a UK laboratory that will be essential for local test processing. This partnership model mirrors Mainz's commercial approach in other European markets, leveraging local laboratory infrastructure rather than building their own facilities—a capital-efficient strategy that accelerates market penetration.
From a regulatory perspective, this approval is particularly valuable as the UK has maintained high regulatory standards post-Brexit. ColoAlert will now complement the existing Bowel Cancer Screening Program that currently uses FIT (Fecal Immunochemical Test) technology for approximately 4 million people aged 50-74 annually. The DNA-based approach of ColoAlert potentially offers enhanced sensitivity compared to standard FIT tests by detecting specific cancer-associated genetic markers.
This approval advances Mainz's commercial footprint and provides validation for their technology as they pursue their broader commercial strategy. For the UK healthcare system, introducing an additional screening option could help address the persistent challenge of screening compliance, potentially increasing early detection rates in a cancer where early diagnosis significantly improves survival outcomes.
BERKELEY, Calif. and MAINZ, Germany, Sept. 02, 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, announces today that ColoAlert® has received official registration with the Medicines and Healthcare products Regulatory Agency (MHRA) and is now authorized for marketing in the United Kingdom.
This milestone follows the technology partnership announced earlier this year with EDX Medical Group plc, a leading UK laboratory, and represents an important step toward making Mainz Biomed’s DNA-based colorectal cancer (CRC) screening test, ColoAlert, broadly accessible to patients across the country.
Colorectal cancer is the fourth most common cancer in the UK, with approximately 44,000 new cases diagnosed annually. ColoAlert provides a non-invasive approach to CRC screening by detecting DNA biomarkers in stool samples. The test aims to complement the existing Bowel Cancer Screening Program, which currently invites around 4 million people aged 50 to 74 to complete a FIT test annually, by providing an additional, accessible option that could help increase participation.
“With the approval, ColoAlert is now cleared for use across the UK,” said Guido Baechler, CEO of Mainz Biomed. “This regulatory milestone enables our UK laboratory partner to provide a reliable and user-friendly test to a large population, supporting our shared goal of increasing participation in preventive screening and, ultimately, saving more lives.”
The approval of ColoAlert in the UK underscores Mainz Biomed’s commitment to expanding access to innovative diagnostic solutions for early cancer detection. By equipping healthcare providers and patients with an additional tool for colorectal cancer prevention, the Company continues to advance its mission of addressing one of the leading causes of cancer-related mortality worldwide.
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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 March 31, 2025. 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 regulatory approval did Mainz Biomed (MYNZ) receive for ColoAlert in the UK?
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