Abbott's highly sensitive troponin blood test for heart attacks cleared by FDA

Red blood cells
Earlier this year, data from a decadeslong study showed high troponin levels could help predict cardiac risks years in the future, and Abbott is pursuing U.S. clearance for its inclusion in routine physicals. (Wikimedia Commons)

Abbott has secured FDA clearance for its highly sensitive troponin blood test, which aims to identify heart attacks hours earlier than previous methods. 

Its Architect Stat test searches for small elevations in the levels of the protein troponin-I, which is released by heart muscle cells when they are damaged. It is designed for patients that enter an emergency room with symptoms and to help doctors confirm the presence and severity of myocardial infarction within two to four hours of admission.

Additionally, Abbott is launching a training partnership program to help U.S. hospital staff incorporate the automated blood test into their ER workflows, which the company says should be used alongside electrocardiograms and other information to diagnose heart attacks. 

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"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," Abbott Diagnostics’ senior medical director of global medical and scientific affairs, Agim Beshiri, said in a statement.

RELATED: Abbott spotlights study data showing its troponin blood test can predict heart disease risks years ahead

According to the company, women often have lower troponin levels than men, which could lead to missed diagnoses. One study, published in the British Medical Journal, found the Architect test spotted twice as many heart attacks in women than standard tests. Already available in Europe and Asia, the test was the first outside the U.S. to offer gender-specific settings and thresholds, Abbott said. 

Earlier this year, Abbott highlighted data from a decadeslong study that showed high levels of troponin in the blood could help predict cardiac event risks years in the future. The company said the research suggests adding the test to routine physicals of healthy middle-aged and older adults. 

The test has already received a CE mark for cardiac risk assessment, and Abbott said it is pursuing U.S. registration in the broad indication.

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