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LAB21 Limited Partners With Top 10 IVD Player to Develop New Aspergillus Molecular Assay


4/10/2012 11:06:13 AM

Cambridge, UK – 10 April 2012 - Lab21 Limited, the global specialist in personalised medicine and clinical diagnostics has entered into an agreement with one of the world’s leading diagnostic businesses to develop, manufacture and distribute a diagnostic assay for the detection of Aspergillus species for the partner’s real time PCR platform. Financial details of the agreement were not disclosed.

Under the agreement Lab21 will use its molecular diagnostic development resource and proprietary intellectual property in the fungal diagnostic area to develop and manufacture the new Aspergillus test as OEM reagents for the partner platform. Graham Mullis, CEO of Lab21, commented: “We are pleased to enter into a new agreement to develop this assay. The MycAssay™ Aspergillus test provides rapid, accurate clinical information that allows health professionals to make life-saving treatment decisions quickly. This agreement follows closely behind the similar deal made with BD last year.” Berwyn Clarke, CSO of Lab21, added: “The platform we will be using for the new assay is one which is becoming increasingly well adopted within clinical diagnostic laboratories worldwide. Independent clinical validation studies have already shown that both the new Lab21 Aspergillus1,2 and Pneumocystis3 assays are setting new standards in clinical diagnosis of these clinically important fungal pathogens. We expect the new assays to be significant components of the growing menu of our partner’s molecular diagnostic portfolio.”

Infection caused by Aspergillus is a leading cause of death in immunocompromised patients, with an estimated 10 million people at risk globally each year. Studies have shown that diagnosis of Aspergillus infection followed by antifungal treatment within the first 10 days of infection reduces mortality from 90 percent to 40 percent – highlighting the need for rapid, accurate testing. Real-time polymerase chain assays using Lab21 technology have been shown to provide significant advantages in sensitivity and specificity over the current culture techniques.

1 Diagnosis of Invasive Aspergillosis by a Commercial Real-Time PCR Assay for Aspergillus DNA in Bronchoalveolar Lavage Fluid Samples from High-Risk Patients Compared to a Galactomannan Enzyme Immunoassay Riccardo Torelli, Maurizio Sanguinetti, Adrian Moody, Livio Pagano, Morena Caira, Elena De Carolis, Leonello Fuso, Gennaro De Pascale, Giuseppe Belle, Massimo Antonelli, Giovanni Fadda, and Brunella Posteraro Journal of Clinical Microbiology, 2011 Oct 19.

2 P2095: Clinical validation of a marketed real-time PCR assay for diagnosis of invasive aspergillosis in patients without haematological cancer J. GuineaC. Padilla, S. Recio, P. Escribano, D. García de Viedma, T. Peláez, P. Muñoz, B. Padilla, P. Gijón, E. Bouza 21st European Congress of Clinical Microbiology and Infectious Diseases 27th International Congress of Chemotherapy (ECCMID 21st, ICC 27th, 2011)

3 Evaluation of two commercial extraction kits and two PCR-based molecular assays for the direct detection of Pneumocystis jirovecii in human bronchoalveolar lavage samples Tonya Watkins, Megan Reller , Karen Carroll, Sean Zhang ISHAM (International Society of Human and Animal Mycology, Berlin 2012 Submitted)

For further information:

Lab21

Berwyn Clarke, CSO

t: +44 (0)1223 395461

e: berwyn.clarke@lab21.com

For media and investor enquiries:

College Hill

Nicole Yost/Gemma Howe

t: +44 (0)20 7457 2020

e: lab21@collegehill.com

About Lab21

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, Manchester and Bridport.

Website: www.lab21.com


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