ViroGates A/S announced the outcome of meeting with the Center for Devices and Radiological Health (CDRH) of the US Food and Drug Administration (FDA). As previously announced in Company announcement 12-2023, ViroGates is supported by Sobi®? to gain market clearance/approval for suPARnostic®?

Turbi latex to be available in the US market to identify patients who may be eligible for treatment with Sobi's drug Kineret®?. ViroGates has filed for a consultation with the CDRH division of the FDA under the Q-Submission scheme. ViroGates sought advice from the FDA regarding several aspects of its analytical method and clinical data packages.

FDA has certain requirements for data supplied to support that products are reliable, reproducible, and consistent, which differs from those applied in ViroGates current CE-IVD file. The FDA has provided input on the additional data that needs to be presented for the FDA to clear suPARnostic®? Tur biobanks for commercial use in the US market.

The data comprise additional US data, and ViroGates will now seek to establish the data from available biobanks. The data will complement the clinical data from three European sites that used su PARnostic®? Turbi Latex during the pandemic for the SAVE-MORE Study.

ViroGates preliminarily estimates that it will be able to submit the required data sometime during the second half of 2025. ViroGates will communicate further once the obtaining of samples has been finalized.