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
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.