Nordic Bioscience's unique biomarker PRO-C3 gets green light for further study in cancer from US FDA in formal Letter of Support

Morten A. Karsdal, Chief Executive Officer of Nordic Bioscience commented:"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." 

Morten A. Karsdal, Chief Executive Officer of Nordic Bioscience commented:"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, M.D., Director Center for Drug Evaluation and Research, FDA² 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."

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) use³.

Nordic Bioscience have a collaboration agreement with Roche Diagnostics to make the PRO-C3 assay broadly available on the cobas® e automated platform.

About Nordic Bioscience

Nordic Bioscience is a Danish biomarker company headquartered in Herlev, Denmark. Nordic Bioscience is engaged in biomarker development using our unique neoepitope technology. We combine our expertise in biomarker development with preclinical and clinical research. This enables us to develop biomarkers that provide fast and objective decision-making for compound selection and development in clinical trials as well as provide value for patients in a diagnostic setting.

For more information about Nordic Bioscience: http://www.nordicbioscience.com/

¹https://www.fda.gov/drugs/biomarker-qualification-program/letter-support-los-initiative

²https://www.fda.gov/media/169332/download

³ The current Elecsys® PRO-C3 prototype immunoassays from Roche Diagnostics, running on a fully automated cobas® e platform, is presently intended for research use only in exploratory studies. Not for use in diagnostic procedures.

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