The structure of the study will follow the design of the European clinical study starting at Q-linea with analytical and retrospective spike-in samples and then expand to US hospitals for the prospective part of the study. The size of the US study will be slightly larger compared to the European study with an expanded analytical study according to FDA guidelines and is planned to include up to 150 prospective patient samples each from participating hospitals. The focus of the study will be antimicrobial susceptibility results for gram-negative bacteria, including fastidious, directly from positive blood cultures.

“It feels fantastic to have started the US clinical study and with the recent strong results from the European study we anticipate an equally strong result from the US study. FDA allowed Q-linea to perform a majority of the US study at the Q-linea site and parts of the reproducibility study at Swedish hospitals and this is of course very positive. Our goals it to submit the 510(k) application to FDA during 2021” said Jonas Jarvius, CEO of Q-linea.