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Blood Test For Heart Attacks Cleared By FDA

3 weeks, 1 day ago

800  0
Posted on Sep 25, 2019, 3 p.m.

The FDA has cleared a highly sensitive troponin blood test aimed at identifying heart attacks hours earlier than other methods called Architect Stat test made by Abbott Diagnostics.

The test searches for small elevations in the levels of protein troponin-l which is released by heart muscle cells when they become damaged, it is designed for those who present at a hospital with symptoms of a heart attack to help doctors confirm the presence and severity of myocardial infarction within the first 2-4 hours of admission to the E.R.

The company is also launching a training partnership program to help hospital staff incorporate the automated blood test into emergency room workflow, which should be used alongside electrocardiograms and other information to help diagnose heart attacks.

"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.

Women often have lower troponin levels than men do, which can cause diagnosis to be missed. The test was found to detect twice as many heart attacks in women than standard testing in a study published in the British Medical Journal. The test is already available in Asia and Europe, and is the first outside of America to offer gender specific thresholds and settings. 

Data indicates that high levels of troponin in the blood can help to predict cardiac risks years in advance, research suggests that it may be beneficial to add a test such as this to routine physical examinations of middle aged and older adults. 

Currently the test has already received a CE mark for cardiac risk assessment, but the company has plans to pursue American registration in the broad indication. 

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