Mainz Biomed and OncoVanguard8 Enter into Agreement to bring ColoAlert to South America
Mainz Biomed (NASDAQ:MYNZ) signed a Memorandum of Understanding with OncoVanguard8 to introduce ColoAlert, a DNA-based colorectal cancer screening test, to South America beginning with Peru. The MOU outlines core commercial, legal and regulatory terms and a go-to-market strategy for an initial territory, with a final distribution agreement targeted within weeks.
The companies identified Peru, Colombia and Ecuador as initial launch markets, where about 17,000 new colorectal cancer cases are diagnosed annually, highlighting demand for early-detection screening solutions that could raise participation and support public health goals.
Mainz Biomed (NASDAQ:MYNZ) ha firmato un Memorandum of Understanding con OncoVanguard8 per introdurre ColoAlert, un test di screening per il cancro colorettale basato su DNA, in Sud America a partire dal Perù. Il MOU delinea i termini commerciali, legali e normativi principali e una strategia go-to-market per un territorio iniziale, con un accordo finale di distribuzione mirato entro poche settimane.
Le aziende hanno identificato Perù, Colombia ed Ecuador come mercati di lancio iniziali, dove si diagnosticano circa 17.000 nuovi casi di cancro colorettale all'anno, evidenziando la domanda di soluzioni di screening per la rilevazione precoce che potrebbero aumentare la partecipazione e supportare gli obiettivi di salute pubblica.
Mainz Biomed (NASDAQ:MYNZ) firmó un Memorando de Entendimiento con OncoVanguard8 para introducir ColoAlert, una prueba de detección de cáncer colorrectal basada en ADN, en Sudamérica, comenzando por Perú. El MOU describe los términos comerciales, legales y regulatorios clave y una estrategia de entrada al mercado para un territorio inicial, con un acuerdo final de distribución proyectado en unas semanas.
Las empresas identificaron Perú, Colombia y Ecuador como los mercados de lanzamiento inicial, donde se diagnostican aproximadamente 17,000 nuevos casos de cáncer colorrectal cada año, destacando la demanda de soluciones de detección temprana que podrían aumentar la participación y apoyar los objetivos de salud pública.
Mainz Biomed (NASDAQ:MYNZ)는 상호 이해각서를 OncoVanguard8과 체결하여 ColoAlert, DNA 기반의 대장암 선별검사를 남아메리카에 도입하고 페루에서 시작합니다. 해당 MOU는 핵심 상업적, 법적 및 규제 요건과 초기 지역에 대한 시장 진입 전략을 개략하고, 몇 주 내에 최종 유통 계약을 목표로 합니다.
양사는 페루, 콜롬비아, 에콰도르를 초기 출시 시장으로 확인했으며, 연간 약 17,000건의 새로운 대장암 진단 사례가 있어 조기 발견 screening 솔루션에 대한 수요를 강조하고, 참여를 높이고 공중 보건 목표를 지원할 수 있습니다.
Mainz Biomed (NASDAQ:MYNZ) a signé un Protocole d'accord avec OncoVanguard8 pour introduire ColoAlert, un test de dépistage du cancer colorectal basé sur l'ADN, en Amérique du Sud en commençant par le Pérou. Le PAA décrit les termes commerciaux, juridiques et réglementaires clés et une stratégie de mise sur le marché pour un territoire initial, avec un accord de distribution final visé dans les semaines à venir.
Les entreprises ont identifié le Pérou, la Colombie et l'Équateur comme marchés de lancement initiaux, où environ 17 000 nouveaux cas de cancer colorectal sont diagnostiqués chaque année, soulignant la demande pour des solutions de dépistage précoce susceptibles d'augmenter la participation et de soutenir les objectifs de santé publique.
Mainz Biomed (NASDAQ:MYNZ) hat mit OncoVanguard8 eine Absichtserklärung unterzeichnet, um ColoAlert, einen DNA-basierten Test zur Darmkrebsfrüherkennung, in Südamerika einzuführen, beginnend mit Peru. Die MOU skizziert zentrale kommerzielle, rechtliche und regulatorische Bedingungen sowie eine Markteintrittsstrategie für ein anfängliches Gebiet, mit einem endgültigen Vertriebsvertrag, der innerhalb weniger Wochen angestrebt wird.
Die Unternehmen identifizierten Peru, Kolumbien und Ecuador als erste Launch-Märkte, in denen jährlich etwa 17.000 neue Darmkrebsfälle diagnostiziert werden, was die Nachfrage nach Früherkennungslösungen unterstreicht, die die Teilnahme erhöhen und die Ziele der öffentlichen Gesundheit unterstützen könnten.
ماينز بيمد (ناسداك:MYNZ) وقع على مذكرة تفاهم مع OncoVanguard8 لإدخال ColoAlert، اختبار فحص سرطان القولون والمستقيم القائم على الحمض النووي، إلى أمريكا الجنوبية بدءاً من Peru. تحدد م.ع.ت الشروط التجارية وال قانونية والتنظيمية الأساسية واستراتيجية دخول السوق لإقليم ابتدائي، مع هدف توقيع اتفاق توزيع نهائي خلال أسابيع.
حددت الشركات Peru, Colombia and Ecuador كأسواق إطلاق أولية، حيث يتم تشخيص حوالي 17,000 حالة جديدة من سرطان القولون والمستقيم سنوياً، مما يبرز الطلب على حلول فحص الكشف المبكر التي يمكن أن تزيد من المشاركة وتدعم أهداف الصحة العامة.
- MOU signed to commercialize ColoAlert in South America
- Target launch markets: Peru, Colombia, Ecuador
- 17,000 estimated annual CRC cases in initial markets
- None.
Insights
MOU to distribute ColoAlert in Peru, Colombia and Ecuador is a constructive commercial step but remains preliminary.
Mainz Biomed and OncoVanguard8 agreed an MOU on
The business impact depends on execution: the MOU signals intent but carries no binding commercial revenue statements. Key dependencies include successful local regulatory clearance, reimbursement or insurance acceptance, and the parties’ ability to convert the MOU into a signed distribution contract and operational rollout. Watch for the finalized distribution agreement within the indicated short timeframe and any regulatory approvals or payer agreements announced thereafter; those events will determine near‑term commercial traction and measurable revenue impact.
OncoVanguard8 is a leading service provider for innovative healthcare products for insurance companies operating in Peru, Colombia and Ecuador
BERKELEY, Calif. and MAINZ, Germany, Nov. 18, 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, today announced the signing of a Memorandum of Understanding (“MOU”) with OncoVanguard8, a distributor of oncological innovations. The collaboration aims to introduce ColoAlert®, a DNA-based colorectal cancer (CRC) screening test, to South America, starting with Peru.
Colorectal cancer continues to represent one of the most prevalent yet largely preventable cancer types on a global scale. In the three initial launch markets Peru, Colombia and Ecuador alone, approximately 17,000 new cases are diagnosed each year, highlighting the pressing demand for effective early detection and preventive strategies. The rollout of a DNA-based CRC screening solution presents a significant step forward, with the potential to markedly raise screening participation, facilitate timely diagnosis, and align seamlessly with national public health initiatives aimed at reducing CRC-related mortality and enhancing long-term population health outcomes.
In their common MOU, Mainz Biomed and OncoVanguard8 have outlined core commercial, legal and regulatory terms as well as the go-to-market strategy for the initial territory to be part of a final distribution agreement aimed to be signed within the next weeks.
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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. The Company is currently running its eAArly DETECT 2 clinical study in preparation for its pivotal FDA 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 blood and stool samples. To learn more, visit mainzbiomed.com or follow us on LinkedIn, Twitter and Facebook..
About OncoVanguard8
OncoVanguard8 is a company focused on identifying and implementing innovative healthcare solutions for Latin America, with a mission to bridge the technological gap in cancer prevention and early detection. Based in Lima, Peru, the company develops strategic partnerships with insurers, hospitals, and healthcare networks to introduce advanced diagnostic technologies and promote equitable access to innovation. Operating across Peru, Colombia, and Ecuador, OncoVanguard8 serves as a regional catalyst for integrating global oncology advancements into local healthcare systems.
For media inquiries as to Mainz Biomed:
MC Services AG
Maximilian Schur / 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 March 31, 2025 and its mid-year report on Form 6-K filed on September 26, 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 did Mainz Biomed announce on November 18, 2025 about ColoAlert (MYNZ)?
Which countries will Mainz Biomed (MYNZ) target first with ColoAlert?
How many colorectal cancer cases are estimated annually in the initial MYNZ target markets?
Does the November 18, 2025 announcement create a binding distribution agreement for MYNZ?
How might the ColoAlert rollout affect screening participation in MYNZ target markets?
