Novel rapid meningitis diagnostic test moves closer to market

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Oct 07, 2011

Belfast Health and Social Care Trust has licened its novel rapid meningitis diagnostic test to HiberGene Diagnostics Ltd, an Irish start-up client company of NovaUCD, the Innovation and Technology Transfer Centre at University College Dublin. The licence grants HiberGene exclusive rights to commercialize the product worldwide.

Diagnosis of meningitis is notoriously difficult, with ambiguous flu-like symptoms initially, which make early diagnosis very challenging. Standard laboratory tests take at least 24 hours, and there is a need for rapid, sensitive, and specific tests to allow earlier confirmation of the diagnosis and earlier treatment.

The new test, which provides a reliable diagnosis in less than 1 hour, was developed by scientists in the Royal Victoria Hospital laboratories. The test uses an emerging molecular method known as loop-mediated isothermal amplification (LAMP) which is a form of rapid polymerase chain reaction, to provide the result.

The new test has the potential to be used in emergency departments instead of hospital laboratories and is currently being evaluated at the Royal Belfast Hospital for Sick Children.

Consultant Paediatrician Professor Mike Shields led the original research project, which was supported by grants from the Meningitis Research Foundation to Queen’s University Belfast and the HSC R&D Division, Public Health Agency, to the Belfast Trust.

Professor Shields said, “Meningitis presents a clinical challenge for the emergency department doctor because the patient’s symptoms can be non-specific. No doctor wants to send a seriously sick child home, which is why this new diagnostic test holds such promise. When this test is available it will have the potential to save many lives.”

Brendan Farrell, CEO, HiberGene Diagnostics said, “Clinical validation of the test has shown a sensitivity of 100% and a specificity of 99.7% which is excellent. HiberGene plans to commercialize the test in the first half of 2012 and is already in discussions with a number of potential distribution partners in the USA and Europe. We look forward to further collaboration with the Trust.”

Source: News Release
NovaUCD - The Innovation and Technology Transfer Centre at University College Dublin
October 6, 2011