Mainz Biomed has started the feasibility phase of its research initiative, the PancAlert project, to develop a non-invasive blood-based screening test for the early identification of pancreatic cancer.
This phase aims to confirm the discovery analysis carried out earlier this year in collaboration with Liquid Biosciences, which yielded specificity and sensitivity of 98% and 95%, respectively, in identifying this cancer in blood samples.
The collaboration with contract research organisation (CRO) Crown Bioscience will focus on verifying a panel of candidate messenger ribonucleic acid (mRNA) biomarkers with clinical relevance.
Mainz Biomed noted that the feasibility stage will test the chosen biomarkers and machine learning-based algorithm in actual clinical blood samples.
The goal is to assess the assay鈥檚 diagnostic performance and reproducibility under controlled lab conditions, utilising a predefined sample set.
The data will inform the potential of the current biomarker panel and algorithm for further development.
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By GlobalDataPending successful feasibility results, Mainz Biomed plans to carry out a validation study with a larger blood sample cohort.
This is a crucial step towards refining the test for clinical use and preparing for regulatory submissions, such as to the US Food and Drug Administration (FDA).
The project is part of the company’s strategy for developing accessible molecular diagnostics to detect cancer early, especially in indications where the present screening tools are either non-existent or limited.
Mainz Biomed CEO Guido Baechler said: 鈥淲e are excited to take this important next step in our PancAlert project.
鈥淓arly detection of pancreatic cancer remains one of the greatest unmet needs in oncology, and we are committed to delivering a solution that can significantly improve patient outcomes.鈥�
In March, Mainz Biomed enrolled the first subject in its eAArly DETECT 2 feasibility study, aimed at assessing its colorectal cancer test.
