Roche gets FDA 510(k) clearance for diagnostic test to detect heart attack

22 January 2017 (Last Updated January 22nd, 2017 18:30)

Roche has secured US Food and Drug Administration (FDA) 510(k) clearance for its Elecsys Troponin T Gen 5 STAT (TnT Gen 5 STAT) blood test to detect a suspected heart attack.

Roche has secured US Food and Drug Administration (FDA) 510(k) clearance for its Elecsys Troponin T Gen 5 STAT (TnT Gen 5 STAT) blood test to detect a suspected heart attack.

The tropopin testing will help in the diagnosis of myocardial infarction and aid in accurate identification of patients experiencing heart attack.

The Elecsys Troponin T Gen 5 STAT test detects cardiac troponin which is released into the blood stream after the cardiac cells are damaged.

"FDA clearance of this new Roche TnT assay is easily the best news in the last decade for emergency medicine patients presenting with chest pain."

 Troponin is considered as the biomarker for the diagnosis of heart attack and is marked as the gold standard in combination with an electrocardiogram (ECG) and signs of ischemia.

The test operates with higher sensitivity and takes time of about nine minutes which enables faster decision-making, while enabling detection of smaller infarctions and facilitate an effective treatment.

Baylor Medical Center Houston physician Frank Peacock said: "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.

“FDA clearance of this new Roche TnT assay is easily the best news in the last decade for emergency medicine patients presenting with chest pain."

The TnT diagnostic tests have demonstrated their clinical disgnostic functionality and have been available since the past seven years across the world.