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HiberGene Gets CE Mark for Rapid Flu Combo MDx

NEW YORK (GenomeWeb) – HiberGene Diagnostics said today that it has received CE marking for its HG Flu A/B Combo test and has launched it in Europe, Asia, and South America.

The test uses nasopharyngeal swabs for the direct detection of the influenza virus and provides a differential diagnosis between the A and B subtypes to facilitate best treatment options.

HG Flu A/B Combo is the Dublin-based firm’s first viral test, and the eighth in total that can be performed on HiberGene's lightweight HG Swift analyzer. Leveraging loop mediated isothermal amplification technology, the instrument can test four samples simultaneously and report results within 30 minutes.

HiberGene Diagnostics CEO Simona Esposito said that with a rapid time to result, the test “can play a transformative role in the way healthcare providers screen and triage potential flu victims.”

The firm said that the launch of the test is well timed ahead of the annual winter flu season.

HiberGene also said that it is finalizing the development of new tests for RSV and for chlamydia and gonorrhoea that it anticipates launching in 2019.

In April, it announced receipt of a CE-IVD mark for its HG Pneumo/Meningo Combo test, an assay for the combined detection of meningococcal and pneumococcal meningitis in untreated cerebrospinal fluid.