“It feels fantastic to have started the clinical study and I look very positively upon the implementation. Everyone has worked very purposefully to achieve this important step that will take us even closer to commercialization next year,” said Jonas Jarvius, CEO of Q-linea.

The pivotal study for Europe is estimated to include 60-80 prospective patient samples from Hvidovre Hospital in Denmark and Uppsala University Hospital, and approximately 600 samples that are analyzed internally. Most of the internal samples consist of so-called spike-in analysis where bacteria collected from different parts of the world with different resistance patterns are analyzed together with blood from healthy donors.

“Since the study will be conducted in a similar way as during the development of ASTar with very good results, we consider the risks for the study to be relatively small. In addition, each antibiotic preparation is assessed separately, which further reduces the risk profile,” said Jonas Jarvius, CEO of Q-linea.

The results of the study will be part of the documentation in the ongoing process for CE-IVD approval prior to the market launch of ASTar.