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HiberGene gets CE mark approval for HG C. difficile test

MDBR Staff Writer Published 19 December 2016

Ireland-based HiberGene Diagnostics has secured CE mark approval for its HG C. difficile test.

HG C. difficile test will help in the rapid and accurate detection of the bacterium, Clostridium difficile (C. difficile) from stool samples within 60 minutes.

The C. difficile is mostly responsible for hospital-acquired diarrhea, which is fatal in elderly and immuno-compromised patients.

According to the company, the commonly used test methods for C. difficile include time-consuming cell culture techniques and frequently insensitive enzyme assays.

HiberGene’s sensitive and specific C. difficile can be performed outside the laboratory setting within an hour.

HG C. difficile is the third of firm’s expanding portfolio tests, which includes Meningococcus and Group B Streptococcus.

The company has recently added direct swab capability to the Meningococcus and Group B Streptococcus tests.

HiberGene CEO Brendan Farrell said: : “The launch of the HG C. difficile test will help in tackling the spread of C. difficile in clinical environments. The spread of C. difficile can cause significant ill health, despite its relative ease to tackle.

“However, the inability to provide a rapid, on the spot, diagnosis can often result in a delay in effective treatment being administered.

“By using the HG C. difficile test, health professionals can now quickly and easily diagnose the presence of the bacterium and provide an effective treatment.”

Hibergene develops and markets molecular diagnostic tests for human infectious diseases. It uses loop mediated isothermal amplification (LAMP) technology in the development of tests.