Gradientech completes clinical sample testing in ongoing FDA 510(k) clinical study
Following successful pre-clinical evaluation studies of the QuickMIC® system in the United States and receiving a Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA), Gradientech initiated the 510(k) clinical study last year. The study evaluates the QuickMIC system and its U.S. market-adapted gram-negative panel at three renowened U.S. clinical sites using fresh patient samples.
All patient samples required for the study have now been successfully collected and analysed – both directly from positive blood cultures and from bacterial isolate colonies – marking a significant milestone in the regulatory process.
“This is a fantastic achievement and I’m deeply grateful to all the dedicated professionals at our clinical sites who support Gradientech in this important collaboration,” says Sara Thorslund, CEO and co-founder of Gradientech. “Reaching this milestone is a decisive step toward bringing QuickMIC to the U.S. market, where it has the potential to make a meaningful impact on healthcare and improve outcomes for sepsis patients with its first-in-class precision and rapid time to result.”
QuickMIC® and its gram-negative panel are CE marked and commercially available in Europe. QuickMIC is classified as a Breakthrough Device by the U.S. Food and Drug Administration and available for Investigational Use Only in the U.S., but not 510(k) cleared.
For further information, please contact:
Sara Thorslund, PhD, CEO
Tel: +46 736 29 35 80
About Gradientech
Gradientech is a leader in ultra-rapid antibiotic susceptibility testing, developing next-generation diagnostics for infectious disease medicine. Our innovative diagnostic solutions aim to save lives, reduce healthcare costs, and combat the spread of antibiotic resistance – one of our greatest global health threats. Gradientech is headquartered in Uppsala, Sweden. Visit www.gradientech.se for more information.