Mainz Biomed, a molecular genetics diagnostics company, has reported positive topline results from a feasibility study evaluating a non-invasive, blood-based screening test for the early detection of pancreatic cancer.
The eAArly DETECT 2 study evaluated 18 licenced biomarkers – including proprietary biomarkers from Liquid Bioscience – across multiple candidate panels to examine assay efficacy and streamline complexity.
The study demonstrated strong clinical accuracy in differentiating pancreatic cancer patients from control subjects. The leading biomarker panel achieved 100% sensitivity and 95% specificity within the 30-person cohort and was also able to distinguish between stages of the disease.
Importantly, the assay identified precancerous lesions that have the potential to progress to malignancy if left untreated. A blood-based test capable of detecting such lesions could enable earlier intervention and treatment, improving patient outcomes.
“Our algorithm and biomarker selection can identify neoplasms in blood. Delivering a blood-based test capable of detecting early stages of disease is a major step toward the early detection – and ultimately the elimination – of pancreatic cancer,” said Guido Baechler, CEO, Mainz Biomed.
Following these results, the company intends to conduct a larger clinical study to finalise biomarker selection using banked samples and to further assess performance across different disease stages.
Additional studies are also planned, including a validation study employing polymerase chain reaction (PCR) technology to analyse a larger blood sample cohort ahead of future regulatory submissions.