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Cambridge, UK – 9 November 2011 - Lab21 Limited, the global specialist in personalised medicine and clinical diagnostics 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 [Torelli R et al. J Clin Microbiol. 2011 Oct 19. [Epub ahead of print].
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.”
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”
For further information:
Berwyn Clarke, CEO
t: +44 (0)1223 395461
For media and investor enquiries:
Nicole Yost/Gemma Howe
t: +44 (0)20 7457 2020
About Invasive Aspergillosis
Aspergillus is an airborne fungus that can infect immunosuppressed patients, for example, those undergoing organ transplantation or treatment for haematological malignancies (a disease called invasive aspergillosis (IA)). IA also 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%.
Lab21 is a global leader in personalised healthcare. It provides diagnostic products and services and supports blood bank screening, medical diagnostics and drug discovery. Lab21 customers include international healthcare providers, pharmaceutical and diagnostic companies. The Products division of Lab21 manufactures immunodiagnostic kits and reagents that are distributed internationally and is focused on infectious diseases for the blood-banking and clinical markets. Our clinical services operations has a growing test portfolio providing companion diagnostics and high technology molecular assays. Lab21's corporate offices are based in Cambridge, UK and South Carolina, with a GMP manufacturing site in Cambridge and other manufacturing facilities in Newmarket, Camberley and Bridport. The Company's investors include Excalibur, Nexus Medical Partners and Medicis Capital. Website: www.lab21.com
An assay is an analytic procedure for qualitatively assessing or quantitatively measuring the presence or amount or the functional activity of a target entity. This can be a drug or biochemical substance or a cell in an organism or organic sample. ...