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FDA Clears Roche Troponin Test

NEW YORK (360Dx) – Roche today announced that the US Food and Drug Administration has cleared the company's troponin test for helping diagnose patients suspected of having a heart attack.

The 510(k) clearance makes Roche the first in vitro diagnostic firm in the US to offer the next-generation troponin test for patients as an aid in diagnosing myocardial infarction, enabling doctors to more accurately identify heart attack patients, the firm said.

It said that chest pains and other symptoms associated with acute myocardial infarction account for about 8 million emergency room visits in the US, but no more than 20 percent of such cases turn out to have actual AMIs. Roche's Elecsys Troponin T Gen 5 Stat blood test can accurately detect lower levels of troponin, aiding in the diagnosis of true AMI, the company said.

The test has been available in the rest of the world for seven years and its clinical diagnostic utility is supported by more than 600 peer-reviewed publications, Roche said. The higher sensitivity of the Elecsys Troponin T Gen 5 Stat test, with its turnaround time of nine minutes, "can significantly accelerate decision-making, and allows the detection of smaller infarctions, thereby maximizing the potential for effective treatment," it added.