Danish biomarker company Nordic Bioscience says its PRO-C3 biomarker assay has received a Letter of Support (LoS) from the US Food and Drug Administration (FDA).
The letter acknowledges and supports further studies 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 chronic diseases with a fibrotic component. In recent years, the concept of tumor fibrosis, which includes the tumor microenvironment, cancer-associated fibroblasts, and the extracellular matrix, has received significant attention. The FDA LoS demonstrated 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 said: “This is the world’s first blood-based tumor fibrosis biomarker for patients with aggressive solid tumors. We believe strongly in the value and performance of our PRO-C3 biomarker and are proud to receive LoS from the FDA. This recognition is in line with our belief in the potential of the biomarker. Ultimately it’s all about helping patients fight cancer by supporting drug developers in bringing treatments to market faster and at lower cost.”
The PRO-C3 biomarker assay measures specific peptide fragments that are released into the bloodstream during type III collagen formation and are associated with associated fibroblast activity and hence tumor fibrosis. Tumor fibrosis is prevalent in a subset of patients in a variety of solid tumor types and is associated with aggressive tumor development and poor overall survival.
Thus, there is an urgent medical need to identify this group of “fibrotic” cancer patients by developing and validating tools that assess risk based on parameters related to tumor fibrosis. Such a tool could serve as a prognostic enrichment biomarker in cancer clinical 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 an adverse outcome.”
The PRO-C3 is measured on an automated Roche Diagnostics cobas e platform, which improves sample measurement robustness and accuracy. The platform also enables the development of future use of in-vitro diagnostics (IVD).
Nordic Bioscience has a partnership agreement with Roche Diagnostics to make the PRO-C3 test widely available on the automated platform cobas e.