Abbott’s high-sensitivity troponin-I test receives CE mark

Abbott has received a CE mark for its High Sensitive Troponin-I test—a diagnostic test designed to predict heart disease even in patients without cardiac symptoms—the company announced this week.

Abbott’s blood test, according to the manufacturer, is the first CE-marked troponin test on the market that could potentially predict the probability of experiencing a heart attack or other adverse cardiac event months to years in advance. The technology uses a biomarker specific to the heart—something new in a landscape where cardiologists rely on indirect variables like cholesterol levels, blood pressure and tobacco use to assess cardiac risk.

“Our ultimate goal as healthcare providers is to prevent the onset of disease, not just treat or manage its consequences,” Nick Mills, MD, a cardiologist and researcher at the British Heart Foundation Centre for Cardiovascular Science at the University of Edinburgh, said in a release. “The addition of a direct biomarker of heart injury to our assessment of risk could help us identify those with disease earlier so we can intervene and prevent future heart attacks. Having access to high-sensitivity cardiac troponin-I testing for this purpose can help Europe lead the world in the detection and prevention of heart disease.”

Mills authored a study that evaluated the impact of troponin tests and found troponin-I levels can indicate an increased risk of coronary heart disease, independent of cholesterol levels. Troponin also helped indicate which patients would benefit most from statin therapy.

Abbott’s test is reportedly able to detect trace levels of troponin in a patient’s bloodstream, which is especially useful in women, who typically have lower troponin levels. Its high sensitivity means physicians could employ the test during a routine blood draw to better determine their patients’ actual risk of cardiac disease.

Agim Beshiri, MD, the senior medical director for global medical and scientific affairs for Abbott’s diagnostics business, said in the release Abbott’s test, combined with traditional risk assessment, could help patients avoid unnecessary testing, medications and costs. 

“We finally have a heart-specific tool when trying to determine a patient’s chances of developing heart disease,” Beshiri said. “This advancement has the potential to transform how doctors and patients prevent heart disease. Because the high-sensitive troponin-I test can be part of any routine health check, it fits easily into existing healthcare practices.”