Nordic Bioscience receives FDA Letter of Support for biomarker in aggressive tumour fibrosis
James Spargo | June 16, 2023 | News story | Research and Development | FDA, Nordic Bioscience, Oncology, Roche, tumour fibrosis
Danish biomarker company Nordic Bioscience has announced that the US Food and Drug Administration (FDA) has awarded it a Letter of Support (LoS) for its PRO-C3 biomarker assay. The letter acknowledges and supports further study of PRO-C3 as a prognostic biomarker in aggressive tumour fibrosis studies.
The biomarker assay detects PRO-C3, a peptide fragment released into the bloodstream during the formation of type III collagen. This activity is associated with fibroblasts and, consequently, tumour fibrosis, which has been shown to appear in a subset of patients across different solid tumour types who have had aggressive tumour progression and poor overall survival (OS).
PRO-C3 is measured on the Roche Diagnostics cobas e automated platform, and Nordic Bioscience and Roche have a current collaboration agreement which will make the PRO-C3 assay available on the platform.
Morten A Karsdal, CEO 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.”
Jeffrey Siegel MD, director at 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.”
James Spargo
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