The current CE-mark applies to the professional use of the test platform Egoo.Health for sale on the European market.
Qlife to expand the Egoo.Health platform with COVID-19 test through licence deal
Qlife announces that it has closed a license and supply agreement with Aidian Oy to access and incorporate their patented SIBA® Technology into the Egoo.Health platform. The companies have conducted a joint successful first test of integrating Aidian’s SIBA technology into the platform. The SIBA technology will enable the Egoo device to test for viruses, first and foremost the SARS-CoV-2 virus to test for COVID-19. Further to the license agreement, Aidian will be the supplier of the chemistries and reagents to Qlife.
Molecular (DNA/RNA) virus testing on the Egoo platform was envisioned for later stage development. Due to recent positive technology integration and the significantly increased demand for virus testing, the company has decided to prioritize and fund the product development immediately.
The collaboration with Aidian to finalize the SARS-CoV-2 test has started and the next steps are focused on further validation studies. There are several critical milestones during the validation phase, and a regulatory approval must be obtained before the product can be launched commercially. However, during the validation phase the test can be sold as a RUO (Research Use Only) product into healthcare settings. Qlife is working in close contact with relevant authorities and potential partners to evaluate different options to achieve an accelerated product validation process.
The Egoo COVID-19 test
In the first phase the Egoo COVID-19 tests will enable decentralized testing to take place anywhere in the care sector by professional health care providers (nurses, care facilities, schools, etc) and without usage of central lab resources. The test is an RNA test with precision on par with laboratory tests performed in hospital central laboratories. The response time is expected to be twenty minutes. This is a significant improvement from the present response time of central labs and the present testing capacity. The positive effects for patients and health care staff are expected to be significant.
Next step for the Egoo COVID-19 test is approval for home use, which in particular will open for home test of COVID-19 and generally for other viruses, helping to take pressure away from the healthcare system, providing overview of infections and potentially lowering the spread as patients stay home.
Qlife initiates validation of the first test for COVID-19 immediately, and directly after validation the Egoo test devices can be used by health care professionals. Simultaneously Qlife will ramp the manufacturing of capsules and devices faster than planned, to meet expected demand of particularly the virus tests.
The product development and registration phase that is initiated now, requires investments of approximately 6 MDKK over the coming months. The company is presently evaluating different funding options including relevant grants.
Qlife sees a substantial potential turnover from providing COVID-19 tests to Healthcare professionals in multiple geographies and segments of the health care sector.
If the current pressure on the healthcare system extends over the coming several months, there may be a temporary delay for Qlifes ongoing projects with PKU and Arthritis. Not so much due to Qlife’s pursuit of the COVID-19 test, but due to our project’s partners – the hospitals and clinics involved in the validation projects -shifting focus to the on-going acute COVID-19 crisis.
The SIBA Technology
“SIBA” refers to Strand Invasion Based Amplification and is an isothermal amplification technology for amplifying a nucleic acid target molecule. Isothermal amplification offers significant advantages over polymerase chain reaction (PCR) in that it does not require thermal cycling or sophisticated laboratory equipment.
SIBA technology is resistant to non-specific amplification, it is able to detect a single molecule of target analyte and does not require target-specific probes. The technology relies on the recombinase-dependent insertion of an invasion oligonucleotide into the double-stranded target nucleic acid.
SIBA is consequently highly specific and able to distinguish closely related species with even single nucleotide specificity in the absence of complex probes or sophisticated laboratory equipment.
The project is initiated with immediate effect, and it is our aim to inform of the progress on a regular basis.
Aidian Oy, former Orion Diagnostica Oy, is a Finnish based IVD company that has almost 50 years of experience in developing and manufacturing reliable, fast and easy to use diagnostic tests especially for primary care. Aidian’s global footprint covers over 60 countries. The QuikRead go® flagship products are used globally with more than 50,000 placed instruments. In addition to own manufacturing Aidian distributes products of well-established IVD companies. SIBA® technology is the proprietary isothermal amplification technology of Aidian Oy.
Qlife expects to CE mark its COVID-19 test for professional use in the Egoo.Health system within short.
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The Nomination Committee consists of the following persons, who together represent approximately 39 percent of the company's shares and votes.