News-Medical spoke to Yourgene health on their efforts during the COVID-19 pandemic, and how they developed an accurate diagnostic test for COVID-19.
What provoked Yourgene health to look into the diagnosis of COVID-19?
Initially, we utilized our expertise and state-of-the-art manufacturing facilities to support the manufacture of components for a COVID-19 test.
However, it was apparent that there was a need for more accurate tests, with lower false-negative rates, that look for more than 1 viral RNA target and have a reliable supply chain. At Yourgene Health we had the right expertise across our product development, contract manufacturing, and service laboratory testing teams to deliver this specification in a short space of time.
We have a wealth of expertise with PCR products and as such developing a diagnostic test for COVID-19 was a natural step for us. The launch of new product lines is one of our major strategic initiatives and the launch of our Clarigene™ range fits this mission.
Globally, there is an unprecedented demand for accurate, fast, and easy to run, molecular SARS-CoV-2 tests and increased testing is the key to the re-opening of economies worldwide.
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How is Yourgene health supporting the COVID-19 effort?
At Yourgene we have launched a CE-IVD COVID-19 test which is available to laboratories who wish to run COVID-19 testing in house. We are also offering a COVID-19 testing service from our own service laboratory.
We are currently working in collaboration with several partners to offer workplace testing to help get people back to work and on-site safely. The test offered is our Clarigene™ SARS-CoV-2 RT-PCR test which is an antigen test to identify those people who are currently infected with COVID-19.
We have also been ensuring that our customers are still receiving the gold standard technical support that they are used to and continuing to supply our other regulated molecular diagnostics products and services across reproductive health and oncology. Throughout this pandemic, our customers have been kept online and able to provide the testing services to their patients.
Can you describe the diagnostic test you have developed for the diagnosis of COVID-19?
The Clarigene™ SARS-CoV-2 test is a CE-Marked RT-qPCR assay that detects the presence of SARS-CoV-2 viral RNA to identify individuals with a current infection with COVID-19. The test looks for dual viral RNA targets for a more reliable result.
The test is simple and easy to set-up and is available in both a low and high throughput version to meet different laboratory needs. The test has high accuracy with a fast turnaround time.
What are the advantages of using the Clarigene test compared to other PCR tests available such as antibody tests?
The PCR tests are molecular tests for active infections. They detect the virus’ genetic material from a swab of the patient's throat or nose. The antibody tests are serological tests that look for the body’s immune response to the infection and therefore are used to identify people who have been infected with COVID-19. Antibodies can usually be detected from about day 5 of an active infection.
The advantages of the Clarigene test over other PCR tests include that the result is available quicker than some other tests, it has a lower false-negative rate than other tests and it is reliable and scalable to meet demand. We are also able to provide a back-up laboratory in Manchester where samples can be diverted and processed should there be any issues with the customer laboratory and we provide excellent and ongoing technical support.
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How accurate is your Clarigene SARS-CoV-2 test?
Clinical validation of the test has shown >99.9% accuracy with no false-positive or false-negative results. Additional studies have shown 100% repeatability data and an average >99.7% reproducibility.
Clinical sample testing presented 100% concordance when compared to the gold-standard reference.
Why have false-negative results from COVID-19 testing been such an industry-wide problem and how does the Clarigene test reduce this?
There have been several issues that have caused higher false-negative rates. These include improper sample collection and poor sample quality. Some tests also look at targets that are not SARS-CoV-2 specific and as such can give false results.
The Clarigene™ SARS-CoV-2 test uses dual viral RNA targets; SARS CoV–2 Envelope (E) gene and Nucleocapsid (N) gene for a more reliable result. These gene targets are SARS-CoV-2 specific, meaning no cross-reactivity with other Coronaviruses. The test also includes a human RNase P control, designed as a true RNA control for lower false-negative results.
Yourgene also includes an internal control that detects improper sample collection or poor-quality samples to give an invalid result, rather than giving a false result.
Do you believe that by having a rapid diagnostic test for COVID-19, we could potentially help to limit the spread of the virus?
This is certainly the aim of providing rapid diagnostic tests, if people can know quickly that they have an infection, they can self-isolate and therefore limit the spread of the virus. Likewise, people they have been in recent contact with can also be alerted that they need to self-isolate and therefore limit the spread.
For example, in the workplace, should someone be found to have COVID-19, the people they have been in contact with can also self-isolate, maintaining the safety of the environment for other colleagues who can remain in work.
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When will your test be readily available for use and be CE approved?
The Clarigene™ SARS-CoV-2 test received its CE mark on Friday 31st July and is now being rolled out through our direct sales teams and distribution network. Additional submissions are in progress for other regulatory jurisdictions.
What are the next steps in your research into COVID-19 diagnostic testing?
We are looking into other respiratory tests to fit alongside tests for COVID-19. In addition, we are offering focused workplace testing packages for different workplaces such as schools, sports clubs, travel industry where they will have different testing requirements.
Where can readers find more information?
Readers can find out more information on our website:
About Yourgene Health
Yourgene Health is an international molecular diagnostics group which develops and commercializes genetic products and services. The group works in partnership with global leaders in DNA technology to advance diagnostic science.
Our product development, research service, and commercial capabilities extend across the lifecycle of DNA test development including regulatory submissions.
Yourgene Health’s first commercialized products are non-invasive prenatal tests (NIPT) for Down’s syndrome and other genetic disorders, targeting a share of an emerging billion-dollar global market.
Prenatal screening is an established clinical practice, but accuracy challenges with traditional methods are driving the need for NIPT and other DNA-based reproductive health testing solutions. Yourgene Health’s customer-focused products and services support all types of customers, irrespective of size, geography, and market maturity. Our commercial footprint is already established in the UK, Europe, the Middle East, Africa, and Asia.
Through our technical expertise and partnerships, Yourgene Health is aiming to extend its genetic testing offering into complementary areas of reproductive health and oncology.
Yourgene Health is headquartered in Manchester, UK with offices in Taipei and Singapore, and is listed on the London Stock Exchange's AIM market under the ticker "YGEN". For more information, visit www.yourgene-health.com and follow us on LinkedIn and twitter @Yourgene_Health.
Yourgene Health presents data demonstrating successful fetal fraction enrichment in NIPT workflows following prolonged blood storage in EDTA tubes