One of the first 18 research and innovation projects funded by the EU to tackle the coronavirus is already delivering results. Researchers involved in the Irish-led 'HG nCoV19 test' project, selected for funding from the EU research and innovation programme Horizon 2020 under the special call launched in January, have obtained approval to put a new rapid point-of-care diagnostic for COVID-19 on the market.

This week, HiberGene, the Irish company coordinating the project, announced that it had obtained the CE marking required for medical devices to be put on the market.

Gary Keating, chief technology officer

Bringing together public and private organisations from Ireland, Italy, the United Kingdom and China, the 'HG nCoV19 test' project developed a new portable diagnostic system to detect viral infection that gives accurate and reliable results in 30 minutes.

Obtained CE marking required

HiberGene, the Irish company coordinating the project, announced that it had obtained the CE marking required for medical devices to be put on the market.

Mariya Gabriel, Commissioner for Innovation, Research, Culture, Education and Youth, said: "This 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 total EU contribution to the project is €930.000, but HiberGene had been supported by EU research and innovation funding since as far back as July 2000.

The researchers have been making use of Horizon 2020 funds for the HG nCoV19 test project since mid-February. Seamus Gorman, CEO of HiberGene, said: “The support of the EU through the Horizon 2020 programme has been instrumental in delivering this project.”

The HG nCoV19 test uses a low-complexity sample preparation method and can give results for samples with high to moderate viral loads, enabling rapid diagnosis of the disease at the early and highly infectious stage of infection.

The partners in the consortium, HiberGene in Dublin, IRCCS Ospedale Policlinico San Martino in Genoa, Queens University in Belfast, and Medcaptain Medical Technologies in China, will continue to work together through the Horizon 2020 project to evaluate potential additional uses of the test, such as compatibility with new specimen types and patient cohorts.

Background

The Commission has been at the forefront of supporting research and innovation and coordinating European and global research efforts since the start of the pandemic.

Since January 2020, €474 million in funding has already been mobilised under Horizon 2020, the EU research and innovation programme to tackle the coronavirus outbreak. In total, the Commission pledged to invest more than €1 billion from Horizon 2020 into urgently needed coronavirus research and innovation as part of the Coronavirus Global Response initiative.

The first emergency call with a budget of €48.2 million, under which HG nCoV19 test is supported, was the first step in this mobilisation. Selected in a fast-track procedure, 18 projects involving 151 research teams from across the EU and beyond immediately started working on developing diagnostics, treatments and vaccines, and on improving preparedness.

Three of these projects received a total of €6.4 million to develop diagnostic systems that allow testing to be done at the point-of-care, thus reducing delays and giving quicker response.