Roche has received US Food and Drug Administration (FDA) 510(k) clearance for its Elecsys troponin T Gen 5 STAT (TnT Gen 5 STAT) blood test for patients with a suspected heart attack.
According to a company release, this next-generation troponin T test from Roche is able to provide accuracy at lower levels of troponin to aid in correctly identifying patients having an acute myocardial infarction.
This test has been available in the rest of the world for the past seven years during, during which it has been studied in over 600 peer-reviewed publications.
“As an emergency doctor whose job is to make decisions on patients with chest pain, my ability to do this safely and accurately is driven by the sensitivity of the troponin assay,” says Frank Peacock, emergency department physician at the Baylor Medical Center, Houston, USA. “FDA clearance of this…assay is easily the best news in the last decade for emergency medicine patients presenting with chest pain.”