The FDA granted a 510(k) clearance for the Elecsys Troponin T Gen 5 STAT blood test for patients with a suspected MI.
Roche, which manufactures and markets the blood test, announced the clearance in a news release on Jan. 19.
The company said that acute MIs account for approximately eight million consultations per year in U.S. emergency rooms, although only 5 percent to 20 percent of the patients are actually having an acute MI.
The Elecysis test can detect early cardiac troponin release and help diagnose patients with an acute MI, according to Roche. The assay, which has a turnaround time of nine minutes, has been available outside the U.S. for seven years and has been featured in more than 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,” Frank Peacock, MD, FACEP, an emergency department physician at Baylor Medical Center in Houston, said in a news release. “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.”