ColoAlert is currently marketed across Europe and in the United Arab Emirates with the intention of beginning its pivotal FDA clinical study in 2022 for U.S. 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. According to a recent press release, Mainz Biomed is advancing its pivotal FDA clinical study in 2022 for U.S. regulatory approval. Notably, MYNZ announced receiving supportive feedback from the FDA on ColoAlert's pre-submission package, setting up its pivotal U.S. clinical trial to commence in Q4 2022.