New, fully automated, CE IVD approved cobas® 4800 set to help meet demand for national screening programmes

Roche Diagnostics in the UK launches today the CE IVD approved cobas® 4800, its new, high speed analyser for testing Chlamydia/Neisseria Gonorrhoeae (CT/NG) and also for the Human Papillomavirus (HPV). This "hi-spec" instrument which was unveiled to a group of hospital laboratory specialists at a recent preview event held at Roche's Diagnostics Headquarters in Burgess Hill, Sussex, offers an unprecedented level of user friendliness combined with high throughput and efficiency.

Today's laboratories are facing increasing workloads in testing for sexually transmitted disease and therefore the ability to do high through-put testing for Chlamydia for example - which, according to recent statistics¹, affects one in ten people aged under 25 - has become increasingly important especially given the high demand fuelled by the Government sponsored Chlamydia screening programme. Also, given the strong evidence of the link between HPV infection and cervical cancer, the cobas 4800 is equally well placed to meet future potential screening initiatives including triage and test of cure. Moreover, the HPV test performed on the cobas 4800 has a high negative predictive value, providing more information for clinicians in the fight against cervical cancer.

The cobas 4800 instrument features state-of-the-art, fully automated swab and urine sample preparation and combines with real-time PCR technology for amplification and detection, plus easy-to-use software that seamlessly integrates in to both extraction and amplification components. Its streamlined workflow and throughput flexibility means that up to 376 CT/NG or 282 HPV samples can be run in a day extending output without extending working hours. Less intensive testing needs can also be accommodated.

Professor Paul Savelkoul of VU University Medical Center, Molecular Microbiology, Amsterdam who undertook a comparison study of the cobas 4800 CT/NG test commented that the instrument was "very promising" and that both the CT and the NG test showed "a high sensitivity and specificity."

Early trialist, Jackie Jamison, Consultant Biomedical Scientist in Cytopathology and Molecular Pathology from Antrim Area Hospital Northern Ireland said: "The system is excellent and the software is very easy to follow. The throughput far exceeds our expectations and I would be very happy to recommend it for our laboratory ."

Paul Eros, Director, Molecular Diagnostics at Roche commented "We are delighted to be able to offer such a unique, efficient and intuitive instrument. Not only does the cobas 4800 deliver improved result accuracy through its high degree of sensitivity, it is also market leading on cost effectiveness as only tests that are requested are paid for. We believe it will be a major asset to molecular testing laboratories throughout the UK and Ireland."

Notes to the Editor
¹The results of the first year of screening has confirmed the feasibility of opportunistic screening outside of GUM clinic settings and the significant disease burden in this population, with 10.1% positivity among women and 13.3% among men. These findings are consistent with the pilot studies." National Chlamydia Screening Programme - Annual Report 2003/04

For further information please visit www.roche.com.

About Roche
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world's largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche's personalized healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2008, Roche had over 80,000 employees worldwide and invested almost 9 billion Swiss francs in R&D. The Group posted sales of 45.6 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan.
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