Gradientech starts its third FDA 510(k) clinical study site
The diagnostics company Gradientech today announces to have started its third FDA 510(k) clinical study site in the US for the QuickMIC® system for ultra-rapid antibiotic susceptibility testing (AST).
Following successful pre-clinical evaluation studies of the QuickMIC system in the US, a breakthrough device designation by the FDA and the start of two FDA 510 (k) clinical study sites in the US, a third hospital has united to ensure comprehensive clinical data collection for the regulatory FDA submission of the QuickMIC system and its gram-negative panel.
The focus of the clinical study is antibiotic susceptibility testing of gram-negative bacteria, both directly from positive blood cultures as well as from bacterial isolated colonies. In addition, both analytical and clinical performance testing is performed at Gradientech.
MD Prof. Jeffrey Bender, member of the Gradientech Scientific Advisory Board comments: “We clinicians always want faster, more accurate, and actionable results when treating patients with life-threatening sepsis. The Gradientech QuickMIC platform delivers them.” Jeffrey Bender is Infection disease physician, Medical microbiologist and Professor of Clinical pediatrics at City of Hope Comprehensive Cancer Center in Los Angeles, USA.
“Now having started all our clinical sites in our on-going clinical study is of course a significant milestone and decisive step forward to bringing QuickMIC to the US market, where it can make an important impact in healthcare with its first-in-class precision and time to results,” says Sara Thorslund, co-founder and CEO at Gradientech.
The ultra-rapid and precise antibiotic susceptibility testing results of QuickMIC® contribute to timely and effective management of sepsis patients, helping clinicians make faster antibiotic treatment decisions. Its modular design offers affordable scaling possibilities, making QuickMIC suitable for 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
About Gradientech
Gradientech is a leader in ultra-rapid antibiotic susceptibility testing, developing next-generation diagnostics for infectious disease medicine. Our product QuickMIC®, classified as a breakthrough device by the U.S. Food and Drug Administration, contributes to the effective management of sepsis patients by supporting antibiotic treatment decisions in record time. This helps 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.
