The structure of the study follows the design of the European clinical study, and the FDA has also approved that a large part of the study is performed in Sweden, something that is unusual, but naturally positive for Q-linea. As a step towards submission to the FDA for clinical approval, the company today announces that the next step has now been started at two Swedish hospitals and at Q-linea. The aim is to evaluate the reproducibility of ASTar (the ability to report the same response each time a sample is analyzed) as part of the US study.

“It’s fantastic to now have started the next part of the American clinical study. The strong results from the European study, where we were able to show a very high reproducibility of 99.6%, make us confident in being able to meet or exceed FDA’s requirement of 95%. The final part of the study is the prospective part (analysis of patient samples) at American hospitals, and we intend to start that part in the near future”, said Jonas Jarvius, CEO of Q-linea.

Based on the US study, Q-linea is working to be able to submit a 510(k) application for the US market next year.