Gradientech starts decisive clinical study in Europe for QuickMIC®
Uppsala, 17 January, 2022. Gradientech AB (publ) announces the start of the clinical study of its diagnostic QuickMIC® system. The clinical study coordinated by the company is aimed to prove the clinical performance of the system and will form the basis for its regulatory CE-IVD approval prior to market launch. The QuickMIC system is developed with the aim to become the fastest diagnostic system on the market for antibiotic susceptibility testing of sepsis samples.
QuickMIC is a diagnostic system for ultrarapid testing of antibiotic resistance intended for clinical microbiology laboratories. The clinical study is aimed at demonstrating the performance and the significant value of QuickMIC to the management of sepsis patients. Ultrarapid antibiotic susceptibility testing helps clinicians to timely decide optimized antibiotic treatment of sepsis patients, which can significantly improve patient outcome. “It feels very positive to start 2022 with this clinical multi-center study. This is the result of years of multidisciplinary innovative work, and we have worked very focused to reach this important milestone. Results from the clinical study will form the basis for a CE-IVD approval prior to market launch,” said Sara Thorslund, CEO of Gradientech.
The study is designed to include approximately 100 prospective sepsis patient samples from several university hospitals in Europe, and in addition 350 contemporary and stock isolates that will be analyzed at the Gradientech microbiology lab. The stock isolates consist of clinical samples that have been sourced from different parts of the world, to cover variations in antibiotic resistance patterns. “This essentially means that we are continuing the internal workflow that we have followed during our system verification. We have seen rapid, reliable, and precise data from QuickMIC gathered up to this point. In addition to completing the clinical study we are now preparing the commercial launch of QuickMIC,” said Sara Thorslund.
For further information, please contact:
Sara Thorslund, PhD, CEO Gradientech
Tel: +46 736 29 35 80
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