Q-linea AB (publ) announced that the company has started the reproducibility part of the clinical study with ASTar for US 510 (k) market approval. 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. Based on the US study, Q-linea is working to be able to submit a 510(k) application for the US market next year.