Gradientech Brings Cefiderocol to Rapid AST in Just Over 3 Hours
Gradientech, a diagnostics company pioneering ultra-rapid antibiotic susceptibility testing (AST), today launches QuickMIC[® ]GN02, an IVDR CE-marked AST panel that delivers susceptibility results for challenging Gram-negative pathogens in just 3 hours and 14 minutes.
Rapid AST is critical when every hour matters. The new panel adds cefiderocol and other important reserve antibiotics to the QuickMIC® portfolio, expanding testing options for multidrug-resistant Gram-negative bacteria and supporting faster, more informed treatment decisions.
Clinical and analytical performance data were strong across the evaluation, with 95.5% essential agreement, 96.0% categorical agreement, 98.9% reproducibility, and 99.6% of quality control results within range, comfortably exceeding regulatory performance requirements.
“QuickMIC GN02 represents a significant expansion of our rapid AST capabilities. Bringing cefiderocol into a rapid AST workflow is an important technical achievement, and we are proud to make this capability available to laboratories”, says Christer Malmberg, CSO at Gradientech. “It expands the clinical value of our QuickMIC platform and, importantly, gives laboratories more opportunities to deliver actionable results within the same rapid workflow.”
“For me, this is also about what we are building as a company”, says Sumi Thaker, CEO of Gradientech. “We want QuickMIC to become a trusted solution for laboratories facing increasingly complex resistance patterns. The team has made real progress, and I look forward to bringing this capability to more laboratories and clinicians.”
The QuickMIC® system is CE marked and commercially available in Europe. QuickMIC has been granted Breakthrough Device designation by the U.S. Food and Drug Administration and is available for Investigational Use Only in the U.S., but not 510(k) cleared.
For further information, please contact:
Sumi Thaker, CEO Gradientech
Christer Malmberg, CSO Gradientech
Tel: +46 (0) 762 01 40 11
About Gradientech
Gradientech develops next-generation diagnostics for infectious disease medicine. Its QuickMIC® system provides ultra-rapid antibiotic susceptibility testing to help clinicians identify the most effective antibiotic treatment faster. By shortening the time to an informed treatment decision, Gradientech aims to improve patient outcomes, reduce healthcare costs and support the global effort against antibiotic resistance, one of the greatest threats to public health. Gradientech is headquartered in Uppsala, Sweden. Visit gradientech.se for more information.