Key highlights:
- Paves way for further testing of the PRO-C3 biomarker assay, which identifies patients with hard to treat ‘fibrotic’ tumours, in further clinical trials.
- US FDA recognizes need for a blood test for cancer aggressiveness which would be ‘potentially more accessible’ for patients than today’s tumour biopsy approach.
- Potential to enable more targeted therapy and bring treatments to market faster and at a lower cost.
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Nordic Bioscience announces that the Company’s PRO-C3 biomarker assay has received a Letter of Support (LoS) from the U.S. Food and Drug Administration (FDA). This letter acknowledges and supports further study of the PRO-C3 biomarker assay as a prognostic biomarker in tumour fibrosis studies.
Nordic Bioscience has a successful track record of developing and marketing biomarkers for research in a broad range of chronic diseases with a fibrotic component. In recent years, the concept of tumour fibrosis, which encompasses the tumour microenvironment, cancer-associated fibroblasts, and the extracellular matrix, has gained significant attention. The FDA’s LoS demonstrates that Nordic Bioscience’s PRO-C3 biomarker is uniquely positioned to support research and clinical trials in this area.
Morten A. Karsdal, Chief Executive Officer of Nordic Bioscience commented: “This is the world’s first blood-based tumour fibrosis biomarker for patients with aggressive solid tumours. We strongly believe in the value and performance of our PRO-C3 biomarker and are proud to receive the LoS from the FDA. This recognition aligns with our belief in the biomarker's potential. Ultimately this is all about helping patients fight cancer by supporting drug developers in bringing treatments to market faster and at a lower cost.”
The PRO-C3 biomarker assay measures a specific peptide fragment released to the bloodstream during formation of type III collagen and associates with activity of associated fibroblasts and hence tumour fibrosis. Tumour fibrosis is prevalent in a subset of patients across different types of solid tumours and is linked to aggressive tumour progression and poor overall survival. Thus, there is a pressing medical need to identify this fibrotic group of cancer patients by developing and validating tools that assess the risk based on tumour fibrosis-related parameters. Such tools can serve as prognostic enrichment biomarkers in clinical cancer trials.
Jeffrey Siegel, M.D., Director Center for Drug Evaluation and Research, FDA added: “We encourage exploration of the PRO-C3 biomarker as a prognostic enrichment biomarker for patients with solid tumours who are more likely to experience adverse outcomes.”
PRO-C3 is measured on the Roche Diagnostics cobas e-automated platform, which enhances the robustness and accuracy of sample measurements. This platform also enables the development of future in-vitro diagnostic (IVD) use.
Nordic Bioscience have a collaboration agreement with Roche Diagnostics to make the PRO-C3 assay broadly available on the cobas e-automated platform.