HiberGene Diagnostics gets EU approval for rapid Covid-19 test
Liam Kiely
Liam Kiely

HiberGene Diagnostics is an Irish medical diagnostics company originally founded in 2009, and based in Sandyford, Dublin. Over several years, the CTO Dr. Gary Keating, along with his scientific advisory board and development team have developed highly accurate tests for Meningococcal Disease (major cause of Meningitis) and Group B Streptococcus (a leading cause of new-born chronic illness that can result in mortality). Initially funded with seed support from Enterprise Ireland, Bank of Ireland Seed Capital Funds along with private investors, €2.1 million was raised to develop the first two products. In 2016 Cantor Fitzgerald led a €6.5 million private equity investment when its clients invested €3.3m, and more recently with a follow-on round in 2019.

HiberGene uses an instrument called the HG Swift, that can test for critical infectious diseases, sexually transmitted diseases and respiratory infections. These tests are rapid with results in less than 60 mins and accurate with 95%+ sensitivity, which is significantly higher than non-molecular tests. They are extremely cost-effective, removing the need to send samples to a large laboratory and thus ending long delays in getting results.

Covid-19 Rapid Molecular Diagnostic Test Approval
In May this year, HiberGene Diagnostics secured European approval for its Covid-19 virus molecular diagnostic test. This was validated in the Mater Private hospital in Dublin and can now be sold across the EU. Positive results are shown in just 30 minutes, negative results are available in under an hour.

The company has now shipped orders to many countries that had pre-ordered tests pending CE approval, including Russia and Eastern Europe. Commenting on the CE Mark for Covid-19 testing, Minister for Business, Enterprise and Innovation, Heather Humphreys TD said:

“I would like to congratulate HiberGene on their announcement– an Irish based company which is answering the call and stepping up to the plate in our national and global effort to defeat COVID-19. Their hallmark as a company is innovation and adaptability, and the awarding of the CE mark to their COVID-19 diagnostic device to facilitate rapid testing is testament to that. I would like to commend them on their wonderful achievement and wish them every success as they bring the product to market and help Ireland and indeed the world to deal effectively with COVID-19.”

The future for HiberGene Diagnostics
An estimated 85% of hospitals do not have molecular technology and most hospitals outsource testing. Hibergene’s mission is to introduce molecular diagnostic technology to such hospitals worldwide for a wide range of tests. The company has already increased its number of distributors since 2016, covering significant markets in Europe, the Middle East and Asia.

Further studies and collaborations to evaluate potential additional uses of the test, such as compatibility with new specimen types and patient cohorts, are planned including clinical evaluations at IRCCS Ospedale Policlinico San Martino in Genoa, Italy; Queens University in Belfast, Northern Ireland; and at laboratories in China, in collaboration with HiberGene’s Chinese distribution partner, Medcaptain Medical Technologies.

With the support of shareholders and partners, HiberGene is providing healthcare workers with technology to meet important clinical needs and save hospitals money. The company seeks to continue commercialising its technology and developing additional tests to use on its platform.

Liam Kiely is a Corporate Finance Director at Cantor Fitzgerald Ireland.

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