Lab21 Announces Successful Aspergillus Assay Evaluation

Lab21 has announced the completion of a commercial PCR test evaluation for invasive Aspergillosis (IA). The prospective evaluation of the MycAssayTM Aspergillus assay 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).

Aspergillus is an airborne fungus that can infect immunosuppressed patients, such as those being treated for haematological malignancies, or those undergoing organ transplantation. The resulting disease, called Invasive Aspergillosis (IA), poses a risk to hospitalised patients such as those suffering with COPD, liver cirrhosis and those taking corticosteroid treatment. There are estimated to be over 200,000 IA cases annually worldwide and over 10M patients at risk. Mortality rates vary by patient group ranging from 30% to 85%.

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, CEO 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”