HiberGene announces CE Marking for combined molecular test for COVID-19 and Flu A/B

HiberGene Diagnostics announces CE Marking for combined COVID-19 and Flu molecular diagnostic test, allowing health officials to test for both illnesses using a single swab.

Following the successful launch of their CE marked fast molecular diagnostic test for COVID-19  in 2020, HiberGene have re-designed and re-validated their Flu test to allow active COVID-19 and Flu A and B infections to be detected and differentiated from a single patient swab sample.

During winter months, significant COVID-19 activity combined with a notable flu season can put substantial burden on global healthcare systems.

The HiberGene platform allows molecular diagnostic testing for both COVID-19 and Flu A and B at the same time, thus reducing the time to result for a complete and accurate diagnosis, the cost of reagents, the number of swabs a patient needs to endure and the time to effective targeted treatment. This means substantial savings for labs and hospitals diagnosing respiratory infections with similar symptoms.

Ultimately, the HiberGene combined testing is vital during periods of co-circulation of COVID-19 and Flu, and saves valuable healthcare resources, while giving superior patient care.

Gary Keating, CTO of HiberGene says

Using HiberGene’s proprietary sample preparation solutions and protocol, a single respiratory swab can now be simply and rapidly processed for both COVID-19 and Flu onboard the portable HG Swift analyser.  Up to four samples can now be tested in parallel for Flu A, Flu B and COVID-19 in 60 minutes on a single HG Swift Plus unit.  High to moderate viral loads can be detected with a simple direct processing protocol, while enhanced sensitivity using an RNA extraction step has also been validated for the new Flu test.

Deirdre Glenn, Head of Lifesciences, Enterprise Ireland said;

Irish lifesciences and medtech companies have delivered a phenomenal response to the COVID-19 pandemic, rapidly delivering new innovations and increasing production of products. Hibergene Diagnostics has been at the forefront of this with the delivery of rapid testing for Covid-19 in response to urgent global demand. This new test combining both COVID-19 and Flu testing will deliver even more efficiency to the COVID-19 response.

EU The HiberGene Covid-19 test development is supported by a grant of €930,000 from Horizon 2020, the EU programme for support to research and innovation.