News & Media
10 October 2024
Pancreatic Stone Protein (PSP) IVD Capsule test has been granted FDA 510(k) clearance
FDA 510(k) clearance for the Pancreatic Stone Protein (PSP) IVD Capsule test has been granted in order to accelerate the Time-to-Detection of Sepsis. This achievement is a huge milestone for this novel biomarker!
PSP has been created to SAVE LIVES in just 5 MINUTES through the detection of sepsis 24-48h earlier than current standards and assist physicians in making quick and accurate decisions in a field where every minute counts!
In Prime Biosciences we are more than proud to have a product like this in our portfolio. We believed in this test from the very first moment and FDA 510(k) clearance along with the EU IVDR certification in 2022 have come to prove that.
PSP is a game changer in the fight against sepsis... Let's spread the news!