Next-generation troponin T test receives FDA clearance
Roche Diagnostics Corp. announced that the FDA has cleared its next-generation troponin T assay for use in patients presenting with suspected MI.
The blood test (Elecsys Troponin T Gen 5 STAT) can accurately detect lower levels of troponin and more rapidly aid in the diagnosis of patients with acute MI, the company stated in a press release.
The test has been available worldwide, with the exception of the United States, for the last 7 years.
According to the release, there are approximately 8 million ED consultations per year in the U.S. pertaining to suspected acute MI, but only 5% to 20% are actual acute MI, and fast diagnosis can reduce cardiac cell death in patients with MI.
“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, from the Department of Emergency Medicine at the Baylor College of Medicine, Houston, TX, said in the release. “FDA clearance of this new [troponin T] assay is easily the best news in the last decade for emergency medicine patients presenting with chest pain.”
Disclosure: Peacock reports financial ties with Roche.