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 an on-demand diagnostic test for real-time management of patients being evaluated for admission to health-care facilities. 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 Home System 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 20 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 Qlife's Egoo Home System.

TEST PROCEDURE

1. 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.

2. 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 Home System. The test reagents is developed by Finish Aidian Diagnostics and licensed to Qlife for the Egoo Home System.

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

The Egoo Home 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 20 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 20 minutes for Egoo to determine a result after a test capsule is loaded into the system.

4. What is Qlife's 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 and commercially available during autumn 2020.

5. When do you expect the test to be available?

We expect to CE-mark the test for diagnostic use within 6 months (autumn 2020). The ultimate goal is to receive approval for home-use for regular people to test for COVID-19. Furthermore, Qlife plans to continue to introduce other virus or bacteria tests like Influenza, RSV and more on the Egoo Home System.

6. How do I get an Egoo Home System at my facility?

Call or send us an email.

7. 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 Home System is required to run the test.

8. Will Egoo Home System be supported?

Of course ...

9. What strains of Coronavirus will be detected by the test?

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

10. Which specimen types will Qlife's test use?

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

11. 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.

FAQS RELATED TO SARS-CoV-2