Positive Results From MycAssay™ Aspergillus Evaluation

Lab21 Limited has announced the completion of an evaluation of a commercial PCR test, its MycAssay™Aspergillus assay, to detect invasive Aspergillosis (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 and the results of the study are published in the US Journal of Clinical Microbiology [Torelli R et al. J Clin Microbiol. 2011 Oct 19].

The single-centre prospective 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 [BAL] 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'