ViroGates A/S announces the successful CE-IVD accreditation of its novel point-of-care finger prick analysis product for the detection of suPAR. The suPARnostic® POC+ product now has full CE-IVD accreditation for use in professional healthcare settings to identify inflammation and immune activation by measuring suPAR. The product will be sold under the brand name suPARnostic® POC+.
The suPARnostic® POC+ development is a collaboration between ViroGates, and Austria based GENSPEED Biotech GmbH and is based on the GENSPEED Technology that allows for quick and fully automated processing of finger-prick blood to help the hospital sector to triage patients better and faster. The analysis takes approximately 20 minutes to conduct. The product can potentially incorporate more biomarkers into the same panel in the future.
ViroGates and GENSPEED attempted to incorporate C-reactive protein during the product development phase, but the results were not within the required quality for clinical use. The plan is to run a comprehensive handling study with a clinical partner to ensure that all product features are adequate in the clinical setting before a full commercial rollout. The commercial rollout is expected to start in First Quarter 2023 and will not have a financial impact on 2022 results.