The current CE-mark applies to the professional use of the test platform Egoo.Health for sale on the European market.
Qlife updates on process for COVID-19 test
Due to increased requests for information on route to market for Qlife’s COVID-19 test the company is updating the following:
After having finalized the licensing agreement to COVID-19 chemistries and reagents and having conducted technology integration to the Egoo platform, Qlife plans over the next few weeks to perform in-house verification studies in order to verify test performance.
Following positive outcome of in-house verification studies, the expectation is to transfer the test into real life settings at a hospital where the test can be further validated on patient samples. Provided that the outcome of such validation study continues to prove that the Egoo COVID-19 test results are equal to laboratory PCR based COVID-19 tests, the company expects that after 3-4 weeks validation in hospitals it will be possible to register the test with initially limited sales.
The company’s production capacity related to devices and COVID-19 capsules is expected to remain limited for some time, and consequently only modest increase in sales volume of the COVID-19 test is expected in the near term, while performance data is still closely monitored and compared to laboratory results.
Once the COVID-19 test has been fully validated in the hospital environment, Qlife will seek to ramp manufacturing of capsules and devices, as the company expects increased demand for decentralized COVID-19 testing over the coming years.
The Egoo COVID-19 test proves the flexibility and versatility of the Egoo platform. The platform is capable of measuring both protein-based and molecular-based (DNA/RNA) test samples including being able to handle various chemistry systems. An example hereof is the company’s CE-marked Hb/CRP test, which runs on the same platform as the COVID-19 test.
The platform collects proprietary test execution algorithms in the Egoo cloud through each capsule which contains specific barcodes that specifies which algorithm and execution protocol to transfer to the device. Results are after analysis displayed on smart phone or laptop.
Qlife intends to continue to update on route to market for the COVID-19 test on a regular basis.
Qlife expects to CE mark its COVID-19 test for professional use in the Egoo.Health system within short.
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FINANCIAL SUMMARY - THIRD QUARTER 2020
In parallel to the ongoing process of preparing and putting together the dossier for the CE-mark, Qlife has submitted an application for placing the product on the market at this stage, as it offer
The Nomination Committee consists of the following persons, who together represent approximately 39 percent of the company's shares and votes.