Mainz Biomed Receives Swiss Regulatory Approval to Market ColoAlert®
Mainz Biomed (NASDAQ:MYNZ) has received regulatory approval from Swissmedic to market ColoAlert®, its non-invasive colorectal cancer screening test, in Switzerland. The approval follows the company's partnership with labor team w ag, a local Swiss laboratory.
The Swiss market represents a significant opportunity, with 2.8 million people (31.4% of the population) in the target age group of 50-74 years. Current colorectal cancer screening participation rates in Switzerland are below 50% despite having over 13 screening programs nationwide. ColoAlert®, designed to detect CRC tumor DNA and other biomarkers in stool samples, aims to improve these participation rates.
Mainz Biomed (NASDAQ:MYNZ) ha ottenuto l'autorizzazione da Swissmedic per commercializzare ColoAlert®, il suo test non invasivo per lo screening del cancro colorettale, in Svizzera. L'autorizzazione arriva dopo la partnership con labor team w ag, un laboratorio locale svizzero.
Il mercato svizzero rappresenta un'importante opportunità, con 2,8 milioni di persone (31,4% della popolazione) nella fascia d'età target 50-74 anni. I tassi di partecipazione agli screening per il cancro colorettale in Svizzera sono attualmente inferiori al 50% nonostante oltre 13 programmi di screening nazionali. ColoAlert®, progettato per rilevare il DNA tumorale del CRC e altri biomarcatori nelle feci, mira a incrementare questi tassi di partecipazione.
Mainz Biomed (NASDAQ:MYNZ) ha recibido la aprobación regulatoria de Swissmedic para comercializar ColoAlert®, su prueba no invasiva de cribado del cáncer colorrectal, en Suiza. La aprobación se produce tras la asociación con labor team w ag, un laboratorio suizo local.
El mercado suizo supone una oportunidad relevante, con 2,8 millones de personas (31,4% de la población) en el grupo objetivo de 50-74 años. Las tasas de participación en el cribado del cáncer colorrectal en Suiza están actualmente por debajo del 50% a pesar de contar con más de 13 programas de cribado a nivel nacional. ColoAlert®, diseñado para detectar ADN tumoral de CCR y otros biomarcadores en muestras de heces, pretende mejorar estas tasas de participación.
Mainz Biomed (NASDAQ:MYNZ)는 스위스에서 ColoAlert®을 판매할 수 있도록 Swissmedic의 규제 승인을 받았습니다. 이 승인은 현지 스위스 검사 기관인 labor team w ag와의 파트너십에 따른 것입니다.
스위스 시장은 50~74세의 대상 연령층에 해당하는 280만 명(인구의 31.4%)으로 중요한 기회를 제공합니다. 스위스의 대장암 검사 참여율은 전국에 13개 이상의 선별 프로그램이 있음에도 불구하고 현재 50% 미만입니다. 대변 샘플에서 대장암 종양 DNA 및 기타 바이오마커를 검출하도록 설계된 ColoAlert®은 이러한 참여율을 높이는 것을 목표로 합니다.
Mainz Biomed (NASDAQ:MYNZ) a obtenu l'autorisation de Swissmedic de commercialiser ColoAlert®, son test de dépistage non invasif du cancer colorectal, en Suisse. Cette approbation fait suite au partenariat avec labor team w ag, un laboratoire local suisse.
Le marché suisse représente une opportunité importante, avec 2,8 millions de personnes (31,4% de la population) dans la tranche d'âge cible 50–74 ans. Les taux de participation au dépistage du cancer colorectal en Suisse sont actuellement inférieurs à 50% malgré l'existence de plus de 13 programmes de dépistage à l'échelle nationale. ColoAlert®, conçu pour détecter l'ADN tumoral du CCR et d'autres biomarqueurs dans des échantillons de selles, vise à améliorer ces taux de participation.
Mainz Biomed (NASDAQ:MYNZ) hat von Swissmedic die Zulassung erhalten, ColoAlert®, seinen nicht-invasiven Test zur Darmkrebsvorsorge, in der Schweiz zu vermarkten. Die Zulassung erfolgt im Anschluss an die Partnerschaft mit labor team w ag, einem lokalen Schweizer Labor.
Der Schweizer Markt bietet eine erhebliche Chance: 2,8 Millionen Menschen (31,4% der Bevölkerung) gehören zur Zielgruppe der 50–74-Jährigen. Die Teilnahmequoten an Darmkrebs-Screenings in der Schweiz liegen trotz mehr als 13 landesweiten Programmen derzeit unter 50%. ColoAlert®, entwickelt, um Tumor-DNA von CRC und weitere Biomarker in Stuhlproben nachzuweisen, soll diese Teilnahmequoten verbessern.
- Regulatory approval obtained from Swissmedic for ColoAlert distribution
- Access to significant market with 2.8 million people in target age group
- Partnership with local Swiss laboratory already established
- Opportunity to improve screening participation rates currently below 50%
- Will face competition from existing screening methods like FIT and colonoscopy
Insights
Mainz Biomed secures Swiss approval for ColoAlert, unlocking access to 2.8M potential screening candidates with established lab partner.
Mainz Biomed has achieved a significant regulatory milestone with Swissmedic approval for ColoAlert®, its non-invasive colorectal cancer screening test in Switzerland. This approval strategically positions the company within a market where 2.8 million individuals (31.4% of Switzerland's population) fall within the recommended 50-74 age screening demographic.
The timing is particularly advantageous as current Swiss colorectal cancer screening participation rates sit below 50% despite established programs nationwide. This presents a clear market opportunity for Mainz Biomed's ColoAlert® test, which offers an alternative to traditional screening methods like the biennial Fecal Immunochemical Test or once-per-decade colonoscopies.
What makes this approval particularly valuable is that Mainz already has its commercialization infrastructure in place through a previously announced partnership with local laboratory partner labor team w ag. With no remaining regulatory hurdles, the company can immediately proceed with market launch, accelerating the revenue timeline.
This approval aligns with Mainz Biomed's decentralized laboratory partnership model, allowing for localized implementation while avoiding the capital intensity of direct market entry. Switzerland represents another proof point in the company's European expansion strategy for ColoAlert®, complementing existing market presence while potentially improving screening compliance rates in a sophisticated healthcare market with established reimbursement pathways.
BERKELEY, Calif. and MAINZ, Germany, Aug. 13, 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®, its non-invasive colorectal cancer (CRC) screening test, has been officially registered and approved for distribution by Swissmedic, the Swiss regulatory and supervisory authority for medicinal products and medical devices.
In Switzerland, CRC screening programs primarily focus on individuals between the ages of 50 and 74, with options for a biennial Fecal Immunochemical Test (FIT) or a colonoscopy every 10 years. The population in the 50 to 74 age group is estimated at around 2.8 million, accounting for approximately
The regulatory approval by Swissmedic follows the Company’s previously announced partnership with a local laboratory in Switzerland, labor team w ag, earlier this year. With this milestone, ColoAlert® is now authorized for use in the Swiss market and will be made available through the partner laboratory’s diagnostic service offering, with no remaining obstacles to the upcoming launch.
ColoAlert® is a non-invasive screening test which is currently marketed in select countries across Europe and is designed to detect CRC tumor DNA and other biomarkers with high sensitivity in stool samples.
“We are pleased to receive regulatory approval in Switzerland,” said Guido Baechler, CEO of Mainz Biomed. “This supports our broader strategy to expand access to reliable CRC screening solutions for early detection for this devastating disease and ultimately to decrease related mortality rates.”
Mainz Biomed continues to focus on expanding ColoAlert®'s reach through decentralized partnerships with laboratories and regional healthcare providers—ensuring broad access and localized implementation of its advanced molecular diagnostics.
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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
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