ColoAlert®
Colorectal Cancer Screening
Pivotal TrialActive (ReconAAsense FDA trial)
Key Facts
Indication
Colorectal Cancer Screening
Phase
Pivotal Trial
Status
Active (ReconAAsense FDA trial)
Company
About Mainz Biomed
Mainz Biomed is a commercial-stage molecular diagnostics company with a mission to transform cancer screening through convenient, at-home tests. Its core achievement is the CE-marked ColoAlert® test for colorectal cancer (CRC), which is marketed in Europe and is undergoing a pivotal FDA registration trial (ReconAAsense) in the U.S. The company's strategy is to penetrate the massive CRC screening market first, then leverage its platform for a multi-cancer early detection (MCED) pipeline, including pancreatic cancer. Recent corporate actions include a planned name change to Quantum Cyber and a $6.0 million private placement to fund operations.
View full company profileTherapeutic Areas
Other Colorectal Cancer Screening Drugs
| Drug | Company | Phase |
|---|---|---|
| Shield (ECLIPSE Study) | Guardant Health | FDA Approved |
| Urine cfDNA Test for Colon Cancer Screening | JBS Science | Development |
| iFOB | Pangea Laboratory | Commercial |
| ColoHealth | New Day Diagnostics | Approved |
| CRC Screening Program | Polymedco | Commercial |
| SimpleScreen CRC | Freenome | Commercial (as LDT) |
| ColoScape™ / QuantiDNA™ | DiaCarta | Commercial |
| ColoSense | Geneoscopy | Approved |
| At-Home Colorectal Cancer Screening | SNT Biotech | Commercial |
| FIT System & Assay Development | Sentinel Diagnostics | Commercial |
| Next-Generation Cologuard® | Exact Sciences | Development |