Danish biomarker company Nordic Bioscience says its PRO-C3 biomarker assay has received a Letter of Support (LoS) from the U.S. Food and Drug Administration (FDA).
The letter acknowledges and supports further study of the PRO-C3 biomarker assay as a prognostic biomarker in tumor 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 tumor fibrosis, which encompasses the tumor 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 saidd: “This is the world’s first blood-based tumor fibrosis biomarker for patients with aggressive solid tumors. 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 tumor fibrosis. Tumor fibrosis is prevalent in a subset of patients across different types of solid tumors and is linked to aggressive tumor 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 tumor fibrosis-related parameters. Such tools can serve as prognostic enrichment biomarkers in clinical cancer trials.
Jeffrey Siegel, director of the 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 tumors who are more likely to experience adverse outcomes.”
Nordic BioScience and Roche Diagnostics collaboration
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.