A GAME-CHANGING test for COVID-19, which produces results within one hour has been approved for sale in the European Economic Area.
The test, created by Dublin-based HiberGene Diagnostics, works by mixing a patient's sample with a solution that is heated for five minutes before a freeze-dried reagent is applied to it.
It is then put through a portable diagnostic instrument, capable of carrying up to four test samples concurrently, which delivers results in 10 minutes.
On average, positive results can be returned within 30 minutes while negative readings are confirmed within 60 minutes, enabling rapid diagnosis of the virus.
The project, which is supported by a grant of €930,000 from Horizon 2020, the EU programme for research and development, has been hailed as a game-changer because of the speed and low costs associated with it.
Crucially, the test does not require any specialised reagents to strip DNA from samples prior to testing.
These in-demand reagents have been in scarce supply across Ireland, resulting in a delay in testing.
Now, following the results of a clinical evaluation study at the Mater Private Hospital in Dublin, HiberGene Diagnostics has been given the CE mark, which is handed to products sold in the European Economic Area that meet high safety, health, and environmental protection requirements.
Seamus Gorman, CEO of HiberGene, said: "HiberGene has responded to this global challenge by leveraging our proprietary technology to accelerate the development of an accurate and reliable test for Covid-19.”
Mr Gorman highlighted the versatility of the new test system, which is suitable for use in either decentralised facilities requiring rapid molecular tests for screening or in centralised labs where additional tests for confirmation or out of hours testing is needed,
"The support of the EU through the Horizon 2020 programme has been instrumental in delivering this project," he added.
"It is exciting to see HiberGene, who are at the forefront of innovation in the delivery of molecular testing for human infectious diseases, use its technology to develop this diagnostic device, which will help address the urgent global demand for testing with fast results," commented Julie Sinnamon, CEO of Enterprise Ireland.
Mariya Gabriel, Commissioner for Innovation, Research, Culture, Education and Youth, European Commission, said highlighted the project as a great example of EU research in action.
"I am encouraged to see that these researchers have risen to the challenge, developed this new diagnostic system so fast, and delivered on one of the aims of our first emergency call. It's crucial to diagnose coronavirus more quickly and more accurately, as it reduces the risk of further spread of the virus," she said.