The current CE-mark applies to the professional use of the test platform Egoo.Health for sale on the European market.
Qlife to develop SARS-CoV-2 total antibody test
The first phase of developing the antibody test will be outsourced to an existing partner and is expected to take approximately three months. Thereafter, the project will be transferred to in-house specialists for integration to the Egoo device, analytical data collection and product optimization. Qlife expects to be able to CE mark for professional use late 2020 and submit a file for CE mark home use during the first quarter 2021.
“With a relatively limited investment we can complement our COVID-19 tests for active viruses and run the antibody tests on our existing device. IgG/IgM antibody tests are currently developing into a very competitive field with a large interest, especially in mass testing solutions, and we see several segments within elderly homes, larger workplaces, sports events etc. which for a long time will have the need for decentralized and fast antibody testing.” comments Thomas Warthoe, CEO Qlife.
Qlife’s total antibody IgG/IgM test will be based on the particle-enhanced Immunoturbidimetry principle that allows quantitative determination of the total concentration of the IgM/IgG antibodies against COVID-19 virus. The principle of particle-enhanced immunoturbidimetry is based on particles coated with SARS-CoV-2 antigens forming complexes with the specific antibodies. If the IgM/IgG antibodies are present in the capillary blood, Egoo will measure signal changes at 570nm that are directly correlated to the total concentration of the total IgM/IgG antibodies. The assay is expected to take between 6-7 minutes using a drop of blood. With this new Egoo IgM/IgG test it will be possible to follow the total antibodies concentration over time. The new Egoo antibody test will be a full quantitative test just like the laboratory-based ELISA test with comparable specificity.
Qlife expects to CE mark its COVID-19 test for professional use in the Egoo.Health system within short.
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Resolution on (A) employee option program; and (B) directed issue of warrants and approval of transfer of warrants
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.