Gradientech starts pre-clinical testing in the US
The diagnostics company Gradientech today announces the starting of pre-clinical testing in the US.
Following the CE-IVD registration of the QuickMIC® system and gram-negative (GN) panel, the commercialisation has started in select European markets. While in Europe most laboratories follow the European Committee on Antimicrobial Susceptibility Testing (EUCAST) guidelines, in the United States antimicrobial susceptibility testing is overwhelmingly performed according to criteria determined by the Clinical and Laboratory Standards Institute (CLSI). In addition to these different governing guidelines, there are also substantial differences in antibiotic prescriptions between the United States and Europe. The company has finalised the design of the first iteration of the gram-negative panel destined for the US market, and expects the initiation of the US regulatory (FDA) clinical evaluations during next year.
“The first European study results, as well as the feedback received from the European clinical collaborators, has been very encouraging. The impressive speed of the QuickMIC system, and the precise MIC values, are expected to make a significant clinical impact in sepsis patient management and possibly antibiotic dosing. While we continue the preparations for the FDA clinical studies using the dedicated US gram-negative panel, we are very pleased to start pre-clinical testing at two reputable US clinical laboratories with the European GN panel”, says Marc van Nuenen, VP Business Development US of Gradientech. Both laboratories have ample experience in evaluating promising, early-access technologies in clinical microbiology, and results generated will be a strong indicator that the product will meet US expectations.
The laboratory within the academic medical institution Medical College of Wisconsin (MCW) in Milwaukee, started testing in June. “We are excited to start the collaboration with Gradientech and being one of the first sites in the United States to evaluate the assay. Rapid identification methods from positive blood cultures have greatly helped improve patient care, but current technologies are limited to genotypic resistance markers. Technologies like the QuickMIC system can perform a rapid AST and result out a MIC, which could further improve sepsis management” says Matthew Faron, Research Director and Assistant Professor of Pathology at MCW.
For further information, please contact:
Marc van Nuenen, VP Business Development US
Tel: +1 919 808 7190
Sara Thorslund, PhD, CEO
Tel: +46 736 29 35 80
Gradientech is leading the field of ultra-rapid antibiotic susceptibility testing. We develop next-generation diagnostics in infectious disease medicine. Our product QuickMIC 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.
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