Mainz Biomed N.V. announced that PancAlert, its screening test candidate for pancreatic cancer has achieved multiple pre-clinical milestones that support the development of this potential first-in-class diagnostic for a deadly cancer indication. The PancAlert project commenced in 2020 with a grant from the German Federal Ministry of Education and Research to develop a non-invasive early detection test for pancreatic cancer, a malignant neoplasm of the pancreas with one of the highest mortality rates of all major cancers. Each year, about 466,000 lives are taken globally, and it's the seventh leading cause of cancer-related death worldwide.

It has one of the lowest survival rates of any cancer, with typically late detection and poor outcomes with standard of care treatment(s). The 5-year overall survival rate is approximately 11% in the U.S. and 9% globally. However, if diagnosis occurs in the early stages of the disease, the survival rate is significantly higher, hence the rationale behind launching the PancAlert initiative.

Mainz Biomed reported the achievement of multiple predefined milestones for the PancAlert project, including achievement of specificity target, collection of a set of characterized clinical samples, selection of potential biomarker candidates, and the development of prototype biomarker tests. The Company will now allocate resources over the next 12 months to determine if the product candidate warrants clinical evaluation. It's possible that PancAlert's technical profile will include functioning as a stool-based test, mirroring the Company's product ColoAlert, a highly efficacious and easy to use at-home detection test for colorectal cancer.

However, given the growing understanding of the role of the microbiome in pancreatic cancer, Mainz Biomed will evaluate Real-Time Polymerase Chain Reaction (“PCR”)-based multiplex detection of molecular-genetic biomarkers and other testing methods in stool samples, and will also evaluate other collection methodologies including saliva, urine and blood.