Gradientech, a diagnostics company, has successfully completed pre-clinical testing of its QuickMIC® system in the US. The tests involved approximately one hundred clinical patient samples and were conducted at two reputable clinical laboratories in the country. The evaluation of Gradientech’s ultra-rapid antibiotic susceptibility testing (AST) system demonstrated excellent performance, which is an encouraging outcome for the upcoming FDA study. The results from this pre-clinical study will be presented at significant microbiology conferences over the next year.
According to Marc van Nuenen, VP Business Development US at Gradientech, the laboratory performance results from the first US pre-clinical QuickMIC evaluations align perfectly with the excellent clinical performance data obtained during the European clinical validation studies. This positive outcome is a promising sign for Gradientech’s ability to serve the US market.
Dr. Matthew Faron, assistant professor of pathology at the Medical College of Wisconsin, expressed his team’s collaboration with Gradientech on a research study evaluating their novel technology. This technology can report Minimal Inhibitory Concentration (MIC) values from positive blood culture bottles within a remarkable 4-hour timeframe. The study’s data yielded promising results, indicating the high accuracy of the assay compared to traditional isolate testing. Dr. Faron also highlighted the exciting potential of rapid AST in improving patient care by significantly reducing the time from infection to susceptibility results. He looks forward to further collaborations and larger-scale multisite evaluations.
It’s important to note that while the QuickMIC system and its Gram-negative panel are CE-marked and commercially available in Europe, they are not yet available for sale in the United States.
The completion of successful pre-clinical testing in the US marks a significant milestone for Gradientech. The positive performance results obtained during these evaluations and the promising feedback from collaborating experts underline the potential impact of the QuickMIC system in revolutionizing antibiotic susceptibility testing. As Gradientech moves closer to gaining FDA approval and making the QuickMIC system available to the US market, the company’s commitment to improving patient care remains at the forefront.
For more information, please contact Marc van Nuenen, VP Business Development US at Gradientech.
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