FDA Clears Architect Stat High-Sensitivity Troponin Test for MI

Megan Brooks

October 02, 2019

The US Food and Drug Administration (FDA) has approved the Architect Stat (Abbott Laboratories) high-sensitivity troponin-I assay, which can detect myocardial infarction (MI) faster and more accurately than other troponin tests, according to the company.

The Architect Stat test detects very low levels of troponin, allowing clinicians to assess patients with suspected MI within 2 to 4 hours of admission, the company said.

"Women may particularly benefit from this technology as they often have lower levels of troponin than men, which could lead to an undiagnosed heart attack with contemporary troponin tests," they add in a news release.

"The addition of Abbott's high sensitivity troponin-I assay to the laboratory's diagnostic testing menu is a great step forward to help laboratory scientists and clinicians better evaluate patients suspected of having a heart attack," Fred Apple, PhD, professor of laboratory medicine and pathology at the University of Minnesota in Minneapolis, said in the release.

The Architect Stat assay has been evaluated in more than 200 studies for its role in identifying heart disease and cardiac events.

In the HiSTORIC study, for example, of more than 30,000 consecutive patients, a single cardiac troponin measurement using the test safely and effectively ruled out MI at presentation.

In addition, as reported by theheart.org | Medscape Cardiology, implementing the early-rule-out pathway for all comers at seven hospitals across Scotland reduced the time in the emergency department (ED) by just over 3 hours (from 10.1 to 6.8 hours; P < .001) compared with standard care. Further, the proportion of patients discharged directly from the ED increased by 57% (from 53% to 74%; P < .001).

"So overall, three quarters of all patients with suspected acute coronary syndrome were managed in our outpatient setting," said study chief Nicholas Mills, MD, PhD, University of Edinburgh, Scotland, at the European Society of Cardiology (ESC) Congress 2019 and the World Congress of Cardiology, where the results were presented.

The assay also offers gender-specific cutoffs, allowing physicians to more accurately diagnose MI in women, the company said. They cite a study in The BMJ in 2015, which found that the test uncovered twice as many MIs in women than standard troponin tests.

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