ColoAlert®
Colorectal Cancer Screening
Key Facts
Indication
Colorectal Cancer Screening
Phase
Pivotal Study
Status
Active (ReconAAsense Trial Ongoing)
Company
About Mainz Biomed
Mainz Biomed is a commercial-stage biotech company dedicated to revolutionizing cancer screening through advanced molecular diagnostics. Its core product, ColoAlert®, is a CE-marked and FDA-registered stool DNA test for the detection of colorectal cancer and advanced adenomas. The company is actively pursuing a pivotal FDA clinical study (ReconAAsense) to gain U.S. market approval and is developing a portfolio of next-generation tests, including PancAlert for pancreatic cancer and a multi-cancer early detection (MCED) panel. Its strategy leverages a proprietary PCR-based platform to deliver accurate, accessible, and non-invasive screening solutions.
View full company profileTherapeutic Areas
Other Colorectal Cancer Screening Drugs
| Drug | Company | Phase |
|---|---|---|
| Cologuard | Exact Sciences | Commercial |
| ColoClear by Circle | Prenetics | Approved/Commercial |
| ColoAlert® (eAArly DETECT) | Mainz Biomed | Clinical Validation |