Gradientech unveals European clinical study data

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The diagnostics company Gradientech today announces the publication of data from the large multicenter clinical study of the QuickMIC® system in collaboration with leading European hospitals. QuickMIC is the today fastest diagnostic system on the market for antibiotic susceptibility testing (AST) of sepsis samples.

Clinical study data from the multicenter performance evaluation of the QuickMIC system shows that QuickMIC is highly accurate compared to the reference testing method for AST, broth microdilution. QuickMIC provides 95.6% agreement with the reference MIC values (Minimum Inhibitory Concentration) and over two times higher precision compared to broth microdilution.

The study includes a large collection of clinical samples as well as contrived challenge samples totalling 559 different organisms. The study confirms the ultra-rapid turnaround time of MIC results from QuickMIC with an average of 3h 13 minutes in the real-world setting.

The clinical study data is currently under consideration for peer-reviewed publication. In the interest of transparency and open data sharing, Gradientech has today made the full study data available through the preprint server MedRxiv, publically available at https://doi.org/10.1101/2024.03.20.24304581. The publication is co-authored by the University Medical Center Hamburg-Eppendorf, Uppsala University Hospital, Örebro University Hospital, Örebro University and Uppsala University.

“I am proud of the work performed by the Gradientech team and thankful to our collaborating hospitals who have been part of evaluating the QuickMIC system. I especially want to highlight the high precision and reproducibility data, indicating that the groundbreaking QuickMIC linear gradient technology can provide a precise MIC value from every single test, which may have important implications for the management of patients with bacterial sepsis”, says Christer Malmberg, Chief Scientist at Gradientech.

The QuickMIC system's ultra-rapid and precise AST results enable sepsis patients to receive specific personalised guidance of the right antibiotic and the right dose 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  

 

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.