The 510(k) clearance of Elecsys® Troponin T Gen 5 STAT (TnT Gen 5 STAT) assay has been eagerly awaited in the USA for many years and will now help their doctors to effectively diagnose and manage patients with a suspected heart attack, also called Myocardial Infarction (MI).
With this launch, Roche becomes the first in vitro diagnostics company to receive FDA clearance for a truly high sensitive Troponin T assay. This follows on from the TnT Gen 5 STAT (named Troponin T-high sensitive in the rest of the world) receiving CE Mark launch in 2009.
Every minute counts
Every 43 seconds1, a person in the U. S. will have a heart attack. A heart attack, also termed acute myocardial infarction (AMI), is a cardiac event in which the blood supply to an area of the heart muscle is interrupted. This causes the cardiac muscle cells to die and to release Troponin into the blood stream. Patients with chest pain and suspected AMI account for approximately 8 million2 of all emergency room consultations in the US. Only a fraction of them (5-20%) have an actual AMI, so a fast diagnosis is critical for proper patient treatment and hospital resource management.