SARS-CoV-2 | TestYourBiomarkers

EGOO IS IMPLEMENTING A

SARS-CoV-2 TEST

A rapid, near-patient test for the detection of the 2019 novel coronavirus that causes COVID-19

EGOO'S SARS-CoV-2

"During this time of increased demand for hospital services, clinicians urgently need a diagnostic test for real-time management of patients being evaluated for admission. An accurate test delivered close to the patient can be transformative - and help alleviate the pressure that the emergence of the 2019-nCoV outbreak has put on healthcare facilities."

Peter Warthoe, CSO, Qlife, 7 min.

SARS-COV-2 PRESS RELEASES

13 NOVEMBER 2020

QLIFE: APPLICATION FOR TEMPORARY APPROVAL IN DENMARK "IN THE INTEREST OF HEALTH PROTECTION" RECEIVES PRELIMINARY REJECTION BY THE DANISH MEDICINES AGENCY

30 OCTOBER 2020

QLIFE CE-MARK FOR COVID-19 TEST DELAYED 2-3 MONTHS – APPLICATION FOR TEMPORARY APPROVAL IN DENMARK DUE TO PUBLIC HEALTH INTEREST SUBMITTED

17 JULY 2020

QLIFE CONTINUES TO WORK WITH PROFESSIONAL SPORTS, NOW ABROAD AND WITHIN CYCLING

12 MAY 2020

QLIFE HAS ENTERED A FIRST STRATEGICALLY IMPORTANT SALES AGREEMENT FOR THEIR COVID-19 TEST

22 APRIL 2020

QLIFE ENTERS AGREEMENT WITH NORDSJÆLLANDS HOSPITAL TO START VALIDATION OF COVID-19 TEST

31 MARCH 2020

QLIFE TO EXPAND THE EGOO.HEALTH PLATFORM WITH COVID-19 TEST THROUGH LICENSING DEAL

EGOO'S

SARS-CoV-2

Qlife has developed an automated molecular test for the qualitative detection of SARS-CoV-2, the virus that causes COVID-19. The test leverages the design principles of our current Egoo Health technology, in which multiple regions of the viral genome are targeted.

The test can provide rapid detection of the current pandemic coronavirus SARS-CoV-2 in approximately 30 minutes with less than a minute of hands on time to prepare the sample.

Egoo's SARS-CoV-2 can be utilized in multiple settings where actionable test results are needed to make informed treatment decisions quickly. The test delivers near-patient results with the same level of performance seen in reference labs. The test is designed for use on Egoo Health System.

TEST PROCEDURE

What are SARS-CoV-2 and COVID-19?

SARS-CoV-2 is the name of the novel Coronavirus strain, short for Severe Acute Respiratory Syndrome Coronavirus 2, responsible for the current global pandemic, SARS-CoV-2 causes the disease named COVID-19.

What is Qlife doing to aid in the detection of SARS-CoV-2?

Qlife is responding to the global need with a rapid and easy-to-use test that enables healthcare providers to obtain a result within 20 minutes of obtaining a patient sample. The test runs on our standard Egoo Health System. The test reagents is developed by Finish Aidian Diagnostics and licensed to Qlife for the Egoo Health System.

How fast is Egoo's SARS-CoV-2 test?

The Egoo Health System test is well suited for pandemic response. From the time a sample (such as a mouth swab) is taken, a result can be obtained in 30 minutes. We call this "sample-to-answer" and it can be achieved faster than any other test available. It takes less than a minute to prepare the capsule with the patient sample and approximately 30 minutes for Egoo to determine a result after a test capsule is loaded into the system.

What is the regulatory plan?

There are several critical milestones during the validation phase, and a CE-mark must be obtained before the product can be launched commercially. After a successful validation and registration phase, the product is expected to be CE-marked.

When do you expect the test to be available?

We are working to CE-mark the test for diagnostic use ASAP. The ultimate goal is to receive approval for home-use for regular people to test for COVID-19 at home. Furthermore, Qlife plans to continue to introduce other virus or bacteria tests on the Egoo Health System.

How do I get Egoo Health System at my facility?

Call or send us an email. Please notice that the system is initially CE-marked for professional use so that a professional healthcare person is required to do the test.

What materials are needed to run a test?

The test capsule is a complete solution containing all the necessary reagents. A patient mouth swap sample is loaded into the capsule and an Egoo Health System is required to run the test.

Will Egoo Health System be supported?

Of course ...

What strains of Coronavirus will be detected by the test?

The test is designed to detect SARS-CoV-2.

Which specimen types is the Egoo test using?

The Egoo Health System works on blood, plasma, nasal or mouth swaps. The Sars-CoV-2 test is currently performed with a mouth swap.

How can I get more information?

This web page will be updated regularly with additional information as it becomes available. Please don't hesitate to get in contact if you have any questions.

Will the Egoo Sars-CoV-2 test also detect virus mutations?

The mutations seen so far including Cluster-5 (Danish mink) and the B117 (British variant) are mutations located in the spike protein. The Egoo test will detect these variants as Covid-19 positives. Thus, the Egoo test will not distinguish between the wild type and the mutant. Consequently, to specifically find the mutant sequence an assay designed for that purpose has to be repeated or sequencing has to be performed. This is usually done by authorities.

FAQS RELATED TO SARS-CoV-2