PRESS RELEASE: Game-changing home self-test for Covid-19 now ready for the Irish market

MyBio is bringing Covid-19 rapid antigen self-tests to Ireland. The simple nasal swab test could be on shelves within weeks

Rapid antigen self-tests for home use could soon play a major role in curbing the spread of the Covid-19 virus and allowing society and the economy to safely reopen in Ireland in tandem with ongoing vaccination efforts. With repeated and regular self-testing, we can transform how we live with the pandemic. Irish society can begin to open up again while allowing individual citizens to play their part. That is according to MyBio, who this week announced they are bringing the first Covid-19 rapid antigen self-tests to the Irish market.

Commenting on the news, Managing Director of MyBio, Dr Linda Nolan said: “This week we formally submitted an application to the Health Products Regulatory Authority (HPRA) for approval of our Rapid Antigen Covid-19 self-tests for sale directly to consumers on the Irish market. The test has already been evaluated by leading state scientists and reference laboratories in Germany and has received approval for at home use from the German medical regulatory authority. It is our view that this approval by a fellow EU Member State means that it should be a very quick turnaround for HPRA approval in Ireland.

“In the UK, a similar application for exceptional use of at-home COVID-19 rapid tests was approved by the UK’s medical regulatory authority back in December. They are now playing a key role in a surge of nationwide testing. Millions of tests are being deployed to parents and families on a weekly basis to allow for repeated at-home testing as children and college students return to schools and universities. In Ireland, hundreds of thousands of students are returning to the classroom over the coming weeks and Education Minister Norma Foley has indicated that she is considering the role that antigen testing could play in schools.

“In parallel with the ongoing vaccination programme, Ireland needs to look at how it can safely and cost-effectively manage the reopening of our schools, society and economy. People are frustrated and exhausted by repeated lockdowns. Rapid antigen self-tests can give them the assurance and security they need that they are taking every precaution to keep themselves, their families, and their communities safe while also allowing society to begin reopening. These tests can play a key role in stopping asymptomatic spread of the virus, in particular.”

Last October, MyBio published a white paper on ‘The Role of Antigen Testing in the Plan for Living with Covid-19’, which argued that Ireland needs to ramp up the scale of its testing in order to track, trace and curb the spread of the virus in the community and to allow society and the economy to safely reopen. The advantage of using rapid antigen testing alongside the state’s PCR test is that they are faster, relatively cheap, and can play a crucial role in picking up asymptomatic individuals in the community. Vocal proponents of mass community antigen testing include leading Harvard epidemiologist, Dr Michael Mina.

Dr Nolan added, “Regular self-testing at home can reduce pressure on our healthcare system. Ireland has been slow to the uptake of antigen testing in favour of the state’s clinical PCR test, which although highly accurate, is time-consuming, expensive and has experienced repeated backlog issues. Antigen testing can quickly identify people with the highest potential to be infectious and allow them to take immediate action to manage their infection, seek medical advice and protect others. At-home testing will help to relieve some of the state’s burden, while also empowering people to be able to take a simple and inexpensive measure to protect themselves and others.

“The rapid antigen self-tests are highly accurate with high sensitivity and specificity. They are simple and more comfortable to use than previous iterations as the test collects the sample from the front area of the nose instead of the nasopharynx. By following simple instructions, people can perform the test at home and have results within 15 minutes. These tests are already in widespread use in Germany. We have them warehoused and ready to be on shelves in retail outlets across Ireland within weeks once we have approval from the HPRA.

“To date there has been no authorisation for self-testing in Ireland. This product is a game-changer and the route to serial Covid-19 testing as it gives people a reliable option to test themselves in the comfort of their own home. By making the Covid-19 rapid antigen test available for home use, we can break new ground in the return to social normality. We have this test available and ready to sell on the Irish market within minutes of approval from the HPRA. It has already undergone rigorous testing and has been approved for home-use by a fellow EU Member State, so we expect this will allow the HPRA to act quickly to approve the tests here. Antigen tests will continue to play an important role in this pandemic in both professional healthcare and home settings and it is essential that Ireland gets fully on board.”

For further information, visit www.mybio.ie

ENDS

Notes to editors:

• Managing Director of MyBio, Linda Nolan is available for media interview upon request.
• MyBio has submitted an Application by a Manufacturer to the Health Products Regulatory Authority (HPRA) for a Regulatory Derogation for a non-CE marked Medical Device for Covid-19.
• The Rapid Antigen Self-Test has received approval in Germany in accordance with Section 11 (1) of the Medical Devices Act (MPG) for antigen tests for self-use by laypeople (self-tests) for the detection of SARS-CoV-2.
• The UK Medicines and Healthcare products Regulatory Agency (MHRA) issued exceptional use authorisation for NHS Test and Trace COVID-19 Self-Test device in December 2020. See here.
• The white paper prepared by MyBio last October on ‘The Role of Antigen Testing in the Plan for Living with Covid-19’ is available to download here.
• Follow MyBio on Twitter: www.twitter.com/MyBioLtd
• Follow MyBio on LinkedIn: www.linkedin.com/company/mybio-ltd/
• Logo file: https://tinyurl.com/y6kr2pox

About MyBio

MyBio is an award-winning Kilkenny-based life sciences company, an accredited diversity supplier and Ireland’s premium supplier of research products, technology, and expertise. As a previous overall winner of the National Enterprise Awards, MyBio has been in business for over 10 years and is at the forefront of innovation, enabling the science that is changing lives for the better.

 MyBio is the exclusive supplier of many of the world’s leading bioscience reagents and healthcare diagnostic devices to the Irish market. Its clients are life scientists based in laboratories across various sectors including academia, government, biotech, diagnostics, forensics, and the pharmaceutical industry.

 How the test is done

The Covid-19 Antigen Self-Test provides a positive or negative result in 15 minutes. It involves taking samples from both nostrils using a swab, which is inserted up to 2-4cm into the nose and rolled around inside the nostril 5 times. The same swab is used to repeat the process for the other nostril to ensure an adequate sample is collected.

The swab is then washed in a reagent, dissolving a specific protein from the surface of the virus. 3 drops of the sample are added to the test cassette and a positive or negative result will be visible after 15 minutes. The result is interpreted by the position and number of lines that appear on the cassette.

The test kit includes detailed step-by-step instructions and a guide on how to accurately interpret results.