Dublin-based HiberGene Diagnostics has successfully completed the CE marking of a new Covid-19 test.
It follows a clinical evaluation study at the Mater Private Hospital in Dublin that demonstrated the efficacy of the test.
The CE mark signifies that products sold in the European Economic Area have been assessed to meet high safety, health, and environmental protection requirements.
The new Covid-19 test uses HiberGene's proprietary molecular reagent format to accurately detect the virus in nose and throat swabs, with the company's small, portable HG Swift instrument able to test four samples concurrently.
Positive results are returned within 30 minutes on average, enabling rapid diagnosis of the disease at the early and highly infectious stage of infection, while negative results are returned within 60 minutes.
The project is supported by a grant of €930,000 from Horizon 2020, the EU programme for research and development.
Seamus Gorman, CEO of HiberGene, said that the Covid-19 pandemic is the greatest challenge to humanity in our lifetimes.
"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 said.
He said that the test is suitable for both decentralised facilities requiring rapid molecular tests for screening and centralised labs requiring additional tests for confirmation or out of hours testing.
"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 today's news is 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," the Commissioner added.