Game-changing Covid home self-test coming to Irish market

Lifesciences entrepreneur Linda Nolan’s MyBio is  bringing the first Covid-19 rapid antigen self-tests to the Irish market.

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.

That’s according to Irish company MyBio headed by entrepreneur Dr Linda Nolan who said that Irish society could begin to open up if citizens play their part through repeated and regular self-testing.

“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”

She said that the company has formally submitted an application to the Health Products Regulatory Authority (HPRA) for approval of the company’s Rapid Antigen Covid-19 self-tests for sale directly to consumers on the Irish market.

Could rapid antigen testing reopen Irish society and economy?

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,” said Nolan.

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.

Speaking with ThinkBusiness in October, Dr Nolan argued 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. She pointed to vocal proponents of mass community antigen testing that include leading Harvard epidemiologist, Dr Michael Mina.

“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,” Dr Nolan added.

By John Kennedy (john.kennedy3@boi.com)

Published: 5 March 2021