Gradientech starts US 510(k) study for QuickMIC® at clinical sites
The diagnostics company Gradientech today announces to have started the 510(k) clinical study for the QuickMIC® system for ultra-rapid antibiotic susceptibility testing at the first two clinical sites, both well-renowned hospitals in the US.
Following successful pre-clinical evaluation studies of the QuickMIC system in the US last year, and with a breakthrough device designation by the FDA, the 510(k) study of QuickMIC and its first gram-negative panel is now initiated at clinical sites in the US. The focus of the clinical study will be antibiotic susceptibility testing results for gram-negative bacteria, both directly from positive blood cultures as well as from bacterial isolated colonies. The 510(k) study will be conducted across multiple sites in the US to ensure comprehensive data collection, in addition to both analytical and clinical performance testing at Gradientech.
“Starting the actual clinical data collection signifies a clear progression towards commercialisation. It showcases how the company has advanced in the US market and we are very optimistic about our new ‘US’ gram-negative panel,” says Marc van Nuenen, VP Business Development US at Gradientech.
“Due to our breakthrough designation, we have had the possibility to discuss the set-up of the clinical study of QuickMIC in detail with the FDA. This in combination with our company’s solid experience in running regulatory clinical studies in Europe gives me confidence that the 510(k) study will proceed smoothly,” says Sara Thorslund, co-founder and CEO at Gradientech. “This is one decisive step forward to bringing QuickMIC to the US market, where it can make an important impact in the healthcare with its first-in class precision and time to results.”
The QuickMIC system's ultra-rapid and precise AST results enable sepsis patients to receive specific personalised guidance on the right antibiotic in record time. The modular design offers affordable scaling possibilities, making QuickMIC attractive to both small and large hospital laboratories. QuickMIC and its Gram-negative panel are CE marked and commercially available in Europe but not yet available for sale in the United States.
For further information, please contact:
Sara Thorslund, PhD, CEO
Tel: +46 736 29 35 80
sara.thorslund@gradientech.se
Marc van Nuenen, VP Business Development US
Tel: +1 919 808 7190
marc.vannuenen@gradientech.se
About Gradientech
Gradientech is leading the field of ultra-rapid antibiotic susceptibility testing. We develop next-generation diagnostics in infectious disease medicine. Our product QuickMIC®, classified as a breakthrough device by the U.S. Food and Drug Administration, allows patients with sepsis to quickly receive specific guidance on the right antibiotic in the right dose. It saves lives, reduces healthcare costs and limits the spread of antibiotic resistance – one of the greatest global health threats of our time. Gradientech is headquartered in Uppsala, Sweden.
Visit www.gradientech.se for more information.
