The Food and Drug Administration (FDA) has granted 510(k) clearance to Roche for its Elecsys Troponin T (TnT) Gen 5 Stat blood test as an aid in the diagnosis of acute myocardial infarction (AMI). With this clearance, Roche has become the first company in the U.S. to provide high-sensitivity cardiac troponin (hs-cTn) testing, although FDA has asked the company to use the term “next generation” in place of high-sensitivity. Hs-cTn testing has been available outside the U.S. for the past 7 years, during which time healthcare providers have rapidly adopted it and more than 600 peer-reviewed publications have supported its clinical diagnostic utility.

As CLN went to print, Roche had not yet released the U.S. label for the TnT Gen 5 Stat. According to the European labels for the assay, the test achieves a less than 10% coefficient of variation at the 99th percentile upper reference limit of 14 ng/L, with a limit of detection of 5 ng/L. The test also provides results in 9 minutes, shortening the time to diagnosis by almost 3 hours when compared with Roche’s conventional TnT test. TnT Gen 5 Stat’s high analytical precision combined with this rapid turnaround time could help accelerate rule-out and rule-in of AMI, enable the detection of smaller infarctions, and also improve risk stratification of patients with elevated TnT levels with and without acute cardiac events.