FDA Clears New Intended Uses for Roche Diagnostics Troponin T Test

Roche Diagnostics received clearance this week from the U.S. Food and Drug Administration (FDA) for the Elecsys® Troponin T STAT test as an aid in the differential diagnosis of acute coronary syndrome, for risk stratification in patients with acute coronary syndrome, and for cardiac risk in patients with chronic renal failure. The test may also be useful for the selection of more intensive therapy and intervention in patients with elevated levels of cardiac Troponin T.

The Elecsys Troponin T test measures the level of Troponin T, a cardiac- specific protein, in a patient's blood. Troponin T is released into the blood when heart cells die, and its presence can help a physician diagnosis heart attack. Additionally, the higher the level of Troponin T, the more at-risk the patient is to suffer another heart attack.

According to the United States Renal Data System, cardiac disease is the leading cause of mortality among kidney dialysis patients. The new FDA clearance means that cardiologists and nephrologists can use the Elecsys Troponin T test to evaluate a kidney disease patient's cardiac risk. A three- year study at the University of Minnesota School of Medicine of 733 end- stage renal disease patients showed that patients with an increased Troponin T level had a 5-fold increase in risk over patients whose Troponin T levels were not elevated.

In addition, four multicenter trials involving more than 7,000 patients have shown that Troponin T is useful to identify patients with acute coronary syndromes who may benefit from anti-thrombotic therapy.

"The FDA clearance for the expanded indications for Troponin T testing in patients with renal failure will change the way we approach the epidemic of cardiovascular disease in this high-risk patient group," said Benjamin Freda, M.D., Department of Internal Medicine, The Cleveland Clinic Foundation. "In patients with renal failure and detectable levels of Troponin T, physicians should initiate a management plan focusing on aggressive risk factor management and consider referral for evaluation of coronary artery disease as well as structural heart disease such as heart failure. With recent reports estimating that there may be up to 8 million Americans with chronic kidney disease, the benefits of Troponin T testing have enormous public health potential. Cardiac Troponin T testing with the highly sensitive assay designed by Roche Diagnostics, will help nephrologists and other physicians caring for patients with renal disease to address the epidemic of cardiovascular disease in this extremely high risk group, using a practical, evidence-based, highly reliable test."

"Roche Diagnostics is a leader in developing tests that evaluate cardiac disease with a broad portfolio that also includes Elecsysâ proBNP," said Heino von Prondzynski, Head of Roche Diagnostics and Member of the Roche Executive Committee. "We are committed to bringing the healthcare community better tests and new applications that ultimately translate into better outcomes for patients."

Roche Diagnostics' Elecsys systems provide all sizes of laboratories with options for performing immunochemistry testing including the MODULAR ANALYTICS E170 module and Elecsys® 2010 Analyzer.