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HiberGene Molecular SARS-CoV-2 Test Gets CE Mark

NEW YORK – Irish molecular diagnostics firm HiberGene Diagnostics said on Wednesday that it received the CE mark for its new rapid molecular test for SARS-CoV-2.

The test is now available in Ireland and internationally.

It is used with the firm's portable HG Swift instrument to test four samples simultaneously and leverages HiberGene's proprietary molecular reagent format to detect the virus in nose and throat swabs. The company added that the assay employs an easy-to-use freeze-dried reagent format. 

Positive test results can be achieved within 30 minutes on average, HiberGene said, while negative results take about 60 minutes.

The CE mark follows the completion of a clinical evaluation study, the Dublin-based company said. Additional studies and collaboration to evaluate other uses for the test, including using new specimen types and patient cohorts, are planned 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 distribution partner there, Medcaptain Medical Technologies.

The project received a grant of €930,000 ($1 million) from Horizon 2020, the EU program for research and innovation.