Qlife announces CE-mark for professional use for its first biomarker capsule on the Egoo Home System.
The Danish MedTech company Qlife Aps announces that it has CE-marked, for professional use, its capsule for measuring Hemoglobin (Hb) and C-Reactive Protein (CRP/inflammation).
The Egoo Home System is an integrated platform consisting of a small device, disposable capsules, each a test for a specific biomarker, and a digital infrastructure that can share data with patient journals or hospital platforms via smartphones and computers. The system can be used at home or by professionals in a laboratory environment, Point of Care (POC) or near‐patient setting (nursing homes, mobile nursing units, etc.).
The CE mark for professional use indicates that the device meets the legal requirements and that the products quality, safety and performance are documented.
“As stated in the prospectus for the ongoing share issue, this is a big milestone for the company. It proves that the system works well and that we can start commercial sales of the product to health professionals. The clinical quality of the self-test is very high, and the potential of enabling access to both the analysis and the monitoring of the user's data is expected to be significant.", says Thomas Warthoe, CEO at Qlife.
The CE mark for professional use is the first step in getting the CE mark for home use that will give Qlife access to the consumer market with the Egoo Home System.
"We are very happy to be able to register our in vitro diagnostic device with the Danish Medicines Agency and apply the CE-mark on our Egoo System that monitor Hb/CRP level from a blood sample in a professional use environment. At the same time, we are now in close contact with Presafe, our Notified Body to agree on a date for submitting our medical device file for the CE-mark for self-test/home-use”, says Pernille Veje, Vice-President QA/RA&E at Qlife.
Thomas Warthoe adds “This is what our team has been working diligently on for a long time and we are proud to say that we can now continue the journey towards reaching both people that are diagnosed with a disease and people that are interested in gaining more insight into their health. One step closer to bringing clinical biomarker testing into the homes".