Gradientech completes successful pre-clinical testing in the US
The diagnostics company Gradientech today announces the successful completion of its pre-clinical testing of the QuickMIC® system in the US.
The pre-clinical testing of the QuickMIC system has included about a hundred clinical patient samples and was performed at two reputable US clinical laboratories. The evaluation of Gradientech’s ultra-rapid antibiotic susceptibility testing (AST) system showed excellent performance and holds promises for the upcoming FDA study. Results from the US pre-clinical study will be presented at significant microbiology conferences during the next year.
“At the conclusion of the first US pre-clinical QuickMIC evaluations, it is very encouraging to have obtained laboratory performance results that are fully in line with the excellent clinical performance data as obtained during the European clinical validation studies. This bodes well for Gradientech and our ability to serve the US market,” says Marc van Nuenen, VP Business Development US at Gradientech.
“My team has recently collaborated with Gradientech on a research study to evaluate their novel technology that is able to report MIC (Minimal Inhibitory Concentration) values from positive blood culture bottles within 4 hours. The results from our data are promising, demonstrating high accuracy of the assay to traditional isolate testing. The role of rapid AST is an exciting space with the potential to improve patient care; a 4-hour turnaround time from bottle positivity significantly improves the time from infection to susceptibility results. We look forward to further collaborations and seeing how the assay performs as they move to multisite evaluations with larger numbers of specimens,” says Matthew Faron, MD, assistant professor of pathology at the Medical College of Wisconsin (MCW), Milwaukee.
The QuickMIC system 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:
Marc van Nuenen, VP Business Development US
Tel: +1 919 808 7190
marc.vannuenen@gradientech.se
Sara Thorslund, PhD, CEO
Tel: +46 736 29 35 80
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.
