Mainz Biomed's Drug in the FDA Approval Process
This section highlights FDA-related milestones and regulatory updates for drugs developed by Mainz Biomed (MYNZ).
Over the past two years, Mainz Biomed has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
ColoAlert. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
ColoAlert FDA Regulatory Events
ColoAlert is a drug developed by Mainz Biomed for the following indication: In the early detection of cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ColoAlert
- Announced Date:
- September 2, 2025
- Indication:
- In the early detection of cancer
Announcement
Mainz Biomed N.V. 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.
AI Summary
Mainz Biomed N.V., a Swiss molecular diagnostics company, has announced that its non-invasive colorectal cancer screening test, ColoAlert®, received official registration with the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). Now authorized for marketing in the United Kingdom, the test can be offered to patients and healthcare providers across the country. This approval follows its European CE mark and marks a key step in Mainz Biomed’s strategy to expand access to at-home cancer screening.
ColoAlert examines a small stool sample for hidden blood and specific DNA markers linked to colorectal cancer and advanced polyps. By enabling testing at home, it aims to increase screening participation and catch cancers earlier. Mainz Biomed plans to collaborate with UK laboratories, distributors and healthcare networks to make the test widely available. The company will also pursue reimbursement agreements, supporting nationwide screening programs and helping detect colorectal cancer sooner.
Read Announcement- Drug:
- ColoAlert
- Announced Date:
- August 13, 2025
- Indication:
- In the early detection of cancer
Announcement
Mainz Biomed N.V announced 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.
AI Summary
Mainz Biomed N.V. announced that ColoAlert®, its non-invasive colorectal cancer screening test, has been officially registered and approved for distribution by Swissmedic, the Swiss regulatory authority for medical devices.
In Switzerland, screening programs target people aged 50 to 74, who make up about 2.8 million residents or 31.4% of the population. Current options include a fecal immunochemical test every two years or a colonoscopy every ten years. Despite over 13 national programs, participation rates remain below 50%.
Following Swissmedic approval and a partnership with a local laboratory, ColoAlert® is ready for launch with no remaining obstacles. The test will be available through the partner’s diagnostic services across Switzerland.
ColoAlert® detects tumor DNA and other biomarkers in stool samples with high sensitivity. Mainz Biomed plans to expand access through decentralized laboratory partnerships, aiming to boost early detection and reduce colorectal cancer mortality.
Read Announcement
Mainz Biomed FDA Events - Frequently Asked Questions
As of now, Mainz Biomed (MYNZ) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Mainz Biomed (MYNZ) has reported FDA regulatory activity for ColoAlert.
The most recent FDA-related event for Mainz Biomed occurred on September 2, 2025, involving ColoAlert. The update was categorized as "Provided Update," with the company reporting: "Mainz Biomed N.V. 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."
Currently, Mainz Biomed has one therapy (ColoAlert) targeting the following condition: In the early detection of cancer.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:MYNZ) was last updated on 9/14/2025 by MarketBeat.com Staff
