Qlife will not respond to preliminary rejection by the Danish Medicines Agency for COVID-19 test – focus on receiving CE-marking by year-end
Qlife has decided not to respond to the preliminary announcement from the Danish Medicines Agency (Lægemiddelstyrelsen) regarding the rejection of the company’s application for temporay approval in Denamark “in the interest of health protection” for the company’s COVID-19 test. The company will instead focus on completing the documentation for CE-marking in accordance with the timeline previously communicated. Qlife expects CE-marking at the turn of the year 2020/2021.
On November 13, Qlife was informed that the Danish Medicines Agency (Lægemiddelstyrelsen) had rejected the application for temporay approval in Denmark “in the interest of health protection” for the company’s COVID-19 test. The company has since had 14 days to respond to the preliminary announcement and now the company has decided to waive this. Instead, Qlife will focus on completing the documentation for CE-marking in accordance with the timeline previously communicated. Qlife expects CE-marking at the turn of the year 2020/2021.
For more information please contact:
Thomas Warthoe, CEO
tw@egoo.health
+45 21 63 35 34
About Qlife
Qlife is a medical device company that seeks to revolutionize the clinical biomarker market for whole blood testing by taking it out of the lab and into the homes. This will facilitate easy access to blood sample results and in turn facilitate increased monitoring of parameters that enables care improvement.
Shares for Qlife are being traded on Nasdaq First North Growth Market in Stockholm with G&W Fondkommission as certified advisor (phone: +46 (0) 8-503 000 50, e-mail: ca@gwkapital.se).
Read more on Egoo.health, Qlifeholding.com or follow us on LinkedIn.