Roche is pleased to announce the launch of the Elecsys® Troponin T high sensitive (TnT hs) assay, for use on cobas® and MODULAR Analytics serum work areas, in the UK and Ireland. This highly sensitive diagnostic assay has been developed to improve the detection and exclusion of myocardial injury in the early stages, demonstrating excellent precision in the range of 0.003-10 ng/ml Troponin T in serum or plasma, and to help identify risk of future coronary events.

Elecsys® TnT hs is the only commercially available assay, which not only meets the precision requirements (<10% coefficient of variation at the 99th percentile of the reference range) set down in the ACC/ESC† and NACB/AACC* definition of myocardial infarction¹, but also demonstrates the best level of assay designation (> 95% measurable normal values below the 99th percentile)². In addition, in a recent comparative evaluation, Elecsys® TnT hs displayed the highest sensitivity (95 %) and negative predictive value (99%) in the diagnosis of unstable angina at presentation³. This excellent sensitivity and precision make the Elecsys® TnT hs assay a valuable and much needed tool for the early detection and exclusion of acute myocardial infarction (AMI).

"Cardiac troponins have revolutionised our ability to diagnose AMI," comments Dr Richard Body, Emergency Medicine Specialist at Manchester Royal Infirmary, "but until recently assays were limited by a lack of sensitivity at the time of presentation and a lack of precision at the lower concentrations above the 99th percentile. The Elecsys® TnT hs assay has the potential to address both of these issues."

"From my point of view as an emergency physician, high sensitivity cardiac troponin assays have great promise for the early exclusion of AMI. In our initial evaluation of the Elecsys® TnT hs assay, it was possible to exclude AMI with 100% sensitivity using a TnT 'rule out' cut-off of <3pg/ml. Our findings confirm those of Reichlin et al who compared several high sensitivity troponin assays3. In his study, the Elecsys® assay was the only one to have 100% sensitivity at any cut-off, offering a great advantage for emergency physicians who want to rule out AMI as soon as possible after presentation."

The Elecsys® TnT hs assay is further indicated for the risk stratification of patients presenting with acute coronary syndrome (particularly in the risk assessment of chronic renal failure patients), providing a valuable aid in the selection of patients who may require more intensive therapy and intervention.

The robustness of the Elecsys® TnT hs assay against interfering factors ensures high result accuracy and consistency in patient follow-up, and the availability of a STAT (9 mins) version for rapid results delivers unrivalled turnaround time for emergency samples.

Roche offers the clinical laboratories the opportunity to consolidate their cardiac marker tests on a single Roche platform. The Elecsys® TnT hs assay is suitable for use on the MODULAR ANALYTICS, cobas® 8000, cobas® 6000, cobas® 4000 and Elecsys® 2010 platforms.

The market leading cardiac portfolio from Roche offers the unique combination of a rapid turnaround time Point of Care (POC) Troponin T test with a higher sensitivity Elecsys TnT laboratory test, thus enabling all medical institutions to deliver consistent and reliable results across hospital departments to support clinicians in their diagnosis of AMI.

Roche offers the largest assay menu (currently 184 tests) available on an automated serum work area. For further information, please contact Roche Diagnostics on 01444 256750

† ACC/ESC: American College of Cardiology/European Society of Cardiology
* NACB/AACC: National Academy of Clinical Biochemistry/Academy of the American Association for Clinical Chemistry

1. Thygesen et al (2007), Universal Definition of Myocardial Infarction. JACC 50 (22)
2. Apple F. (2009) A New Season for Cardiac Troponin Assays: It's Time to Keep a Scorecard. Clin Chem 55 (7): 1303-1306
3. Reichlin et al (2009) Early Diagnosis of Myocardial Infarction with Sensitive Cardiac Troponin Assays. N Engl J Med 361:858-67

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 personalised 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. For more information: www.roche.com.

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