FDA approves Abbott’s Architect Stat test

The FDA has granted approval to Abbott’s highly sensitive troponin blood test, which aims to identify heart attacks much earlier than previous methods. The Architect Stat test looks for small elevations in the levels of the protein troponin-I, which is released by heart muscle cells when they are damaged, and is designed for patients that attend A&E with symptoms and to help doctors confirm the presence and severity of myocardial infarction within two to four hours of admission. It should be used alongside electrocardiograms and other information to diagnose heart attacks, and has already received a CE mark for cardiac risk assessment.
Abbott Diagnostics’ senior medical director of global medical and scientific affairs, Agim Beshiri, said: “As one of the most widely researched high sensitivity troponin tests, this technology could help address several challenges in emergency departments today, including overcrowding and more accurately identifying heart attacks in women.”