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9 November, 2011 - 13:17 By News Desk

Lab 21 makes fungal diagnostics breakthrough

Lab21 is a global specialist in personalised medicine and clinical diagnostics

Lab21 Limited in Cambridge has made a breakthrough in fungal diagnostics to combat a dangerous invasive infection.

An evaluation of a commercial test of its new assay suggests the UK company has stolen a global march in the detection of invasive Aspergillosis (IA).

Lab21, a global specialist in personalised medicine and clinical diagnostics, reports a successful test of its MycAssay Aspergillus assay, to detect IA in a mixed population of 158 patients with underlying haematological or critical illness.

The prospective evaluation was performed by Professor Sanguinetti’s team at the Institute of Microbiology in Rome.

The vast majority of cases of IA are the result of the patient being immunocompromised – their immune systems are not working as efficiently as they could. The reason could be one of a few causes, including chemotherapy & radiotherapy for cancer treatment ; bone marrow transplant; the use of immunosuppressive drugs after a transplant; genetic defects; diabetes; AIDS or overuse of some steroids.

Some organs are 'less well' protected by the immune system as they have a less rich blood supply.

The Lab21 evaluation tested the reliability and performance of the Myconostica assay compared with clinical diagnosis and conventional diagnostic tests, such as culture and one of the current commercial gold-standards which is based around the detection of galactomannan (GM) in serum.

The data generated from bronchoalveolar lavage samples showed that MycAssay Aspergillus is a sensitive and specific molecular test for the diagnosis of IA which, in these early studies, appears to perform better than other assays in the study and is far superior to culture.

Berwyn Clarke, CSO at Lab21 said: “The results of this evaluation confirm that our new CE-marked assay for the diagnosis of IA represents a first-in-class addition to fungal diagnostics enabling faster, more reliable and sensitive case detection. We are in the process of conducting additional studies to firmly establish its clinical utility in high-risk settings.”

Professor David Denning, University of Manchester, an expert in fungal disease added. “Invasive aspergillosis is usually a hidden, clinical silent disease. Early detection of IA is critical for improved patient outcomes.

“Current tests are insensitive or suffer from false-positive and false-negative results. These new data are very promising in the context of haematological or critical illness and hopefully can be introduced into routine fungal disease guidelines at the earliest opportunity.”

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