Regulatory Filings • Dec 10, 2020
Regulatory Filings
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Q-linea AB (publ) (OMX:QLINEA), today announced that the company has started the pivotal clinical study for ASTar in Europe.
"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.
Jonas Jarvius, CEO, Q-linea AB [email protected] +46 (0) 70-323 77 60
Anders Lundin, CFO, Q-linea AB [email protected] +46 (0) 70-600 15 20
Q-linea is an innovative infection diagnostics company that primarily develops instruments and disposables for rapid and reliable infection diagnostics. Our vision is to help save lives by ensuring antibiotics continue to be an effective treatment for future generations. Q-linea develops and delivers preferred solutions for healthcare providers, enabling them to accurately diagnose and treat infectious disease in the shortest possible time. The company's lead product ASTar® is a fully automated instrument for antibiotic susceptibility testing (AST), giving a susceptibility profile within six hours directly from a positive blood culture. For more information, please visit www.qlinea.com.
This information is information that Q-linea is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 2020-12- 10 15:40 CET.
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