Research & Development
Q-linea reports receipt of positive response from FDA for design of planned ASTar clinical study
31 October 2019 -

Q-linea AB (STO: QLINEA) announced on Wednesday the receipt of the official response, including a number of clarifications and a very positive feedback, from the US Food and Drug Administration (FDA), regarding the company's planned pivotal clinical trial with ASTar in the US.

According to the company, with this feedback it has received the clear guidance it wanted and believes that the study can now be carried out in a more straightforward way than previously estimated, as the FDA offers the possibility for Q-linea to perform parts of the study itself. This is reportedly good news that might also have benefits regarding the study's total cost and timeline.

This pivotal study with ASTar relates to the clinical and analytical performance of the system and will be conducted at three sites, two in the US and one in Europe, of which one is expected to be Q-linea's microbiology laboratory in Uppsala.

The study is expected to start in the second half of 2020.

Q-linea is a research, development and manufacturing company that primarily develops instruments and disposables for rapid and reliable infection diagnostics.

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