Lab21 Announces Positive Results for Aspergillus Detection in Critical Care and Haematology Patients

11-14-2011: Lab21 Limited has announced the completion of an evaluation of a commercial PCR test, its MycAssayTM 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.

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 MycAssayTM 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.”