ViroGates A/S announced the commercial launch of its newly developed suPARnostic POC+ product for complete quantitative analysis of suPAR in finger prick blood. suPARnostic POC+ was approved according to CE-IVD in 2022. Before commencing the commercial roll-out, ViroGates wanted to collect additional clinical and handling data from users with limited or no experience handling finger prick blood analysis.

Topline data from a Greek study comprising two hospitals have been released, showing a robust and highly statistically significant correlation between finger prick blood samples and a reference blood sample processed using existing EDTA plasma samples on the suPARnostic ELISA platform. Clinical data from the study have also been analyzed, showing a strong and highly statistically significant ability to predict patient outcome (based on 30 days mortality data). The data support the ability of the target customer segment, doctors, nurses and other healthcare personnel not trained as professional lab users, to run suPAR analysis near patients with results that can be obtained in approx.

20 minutes. The suPARnostic POC+ development is a collaboration between ViroGates, and GENSPEED Biotech GmbH. It 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 product may incorporate more biomarkers into the same panel in the future. ViroGates and GENSPEED are collaborating in a program supported by an EU grant to exploit the ability to add to the POC+ additional relevant, complementary biomarkers. The commercial rollout will now be initiated by ViroGates' salesforce and its distribution partners across Europe.

Data analysis of the Greek study is ongoing, and final results will be made available via publication in a scientific journal. The results from this announcement are not expected to impact ViroGates' full-year 2023 revenue or EBIT guidance. ViroGates' strategic objective of becoming cash flow positive during 2024 is maintained.