Nordic Bioscience, a leading biomarker company, yesterday announced that the company’s extracellular matrix (ECM) biomarker, PRO-C3 (nordicPRO-C3™) will be available as a research use-only (RUO) product in China at LabCorp. All testing outside China continues to be offered exclusively at Nordic Bioscience’s laboratories in Herlev, Denmark. The availability of PRO-C3 as RUO in China will allow drug developers and scientists in China pre-IVD access to PRO-C3, which will be offered via LabCorp in Shanghai.
The PRO-C3 biomarker is relevant for drug development in particularly chronic diseases with a fibrotic component e.g., non-alcoholic steatohepatitis (NASH, also known as MASH), idiopathic pulmonary fibrosis (IPF) and multiple cancer types with solid tumours.
“This collaboration will allow faster and broader access to Nordic’s precision medicine enabling biomarker PRO-C3. We are very happy to be able to help drug developers in their efforts to bring new drugs for debilitating and deadly chronic diseases to market faster, more cost-efficiently, and in the future, have the potential to improve patients’ lives” said Morten A. Karsdal, Chief Executive Officer of Nordic Bioscience.
The PRO-C3 biomarker quantifies the formation of type lll collagen via measurements in blood samples. Moreover, the FDA has recently issued a Letter of Support for further investigations of the PRO-C3 biomarker as a proposed prognostic biomarker in clinical trials of patients with solid tumours. Tumour fibrosis is a common denominator in a proportion of patients across solid tumour types and is associated with a more aggressive tumour progression and poor overall survival.
The PRO-C3 biomarker assay is measured on the fully automated cobas® e platform from Roche. Until now it has only been possible to measure PRO-C3 in the Nordic Bioscience laboratory in Herlev, Denmark, but RUO availability in China facilitates broader market access.
The license agreement between Nordic Bioscience and Roche will put multiple Nordic Bioscience biomarkers on the fully automated cobas® e platform from Roche over the coming years. This enables better research and drug development in chronic diseases in which the ECM and collagens are central components. That is the case for almost 50 chronic diseases that until now have limited treatment options and represent a major challenge for patients and society.