Abbott Receives CE Mark for High Sensitive Troponin-I Test

October 16, 2018 — Abbott announced that its High Sensitive Troponin-I blood test has received CE Mark for distribution in Europe. It is the first troponin test with CE Mark that can more accurately predict the chances of having a heart attack or other cardiac event potentially months to years in advance in people who otherwise appear healthy.

Cardiovascular diseases are the leading cause of death globally.1 Yet unlike other conditions, heart disease can be prevented if identified early and managed through lifestyle changes and medication as needed.  This technology has the potential to transform how doctors identify those at risk for developing heart disease because the diagnostic test uses a biomarker specific to the heart. European guidelines currently recommend that doctors look at indirect heart health factors, such as a person's cholesterol levels, blood pressure, as well as if they have diabetes or are a smoker, to determine risk for developing heart disease.2 A substantial body of research has shown that measuring a person's troponin levels using Abbott's High Sensitive Troponin-I test provides better predictive information for determining a person's chances of developing future heart disease when added to the current standard of care.3-7

Nick Mills, M.D., a cardiologist and researcher at the British Heart Foundation Centre for Cardiovascular Science at the University of Edinburgh, is an author of one such study that evaluated the impact of troponin tests. The West of Scotland Coronary Prevention Study (WOSCOPS) found that troponin-I levels were an indicator of an increased risk of coronary heart disease independent of cholesterol levels lowering, and identified the patients who benefited most from preventive treatments with a statin.4

"Our ultimate goal as healthcare providers is to prevent the onset of disease, not just treat or manage its consequences," said Mills. "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."  

Troponin-I proteins are released from the heart and can be found at elevated levels in the blood when the heart muscle has been damaged due to lack of blood flow. Abbott's ARCHITECT STAT High Sensitive Troponin-I blood test has been used in emergency rooms across Europe over the past five years to help physicians detect heart attacks faster and more accurately, particularly among women who often have lower troponin levels.8

Because the High Sensitive Troponin-I test can detect very low levels of troponin, the test now can be used to determine cardiac risk in people with no reported symptoms of heart disease. Using this diagnostic test during the same blood draw of a routine health exam, doctors will be able to look at what's actually happening to the heart and better determine their patients' risk of developing heart disease, such as a heart attack or other cardiac event, in the future. With this added information, doctors can help ensure the correct treatment is given to people at high risk and prevent unnecessary testing, medication and costs for lower-risk patients.

In addition to more accurately determining a patient's cardiac risk, Abbott's High Sensitive Troponin-I test is designed so that biotin does not affect test results. The vitamin biotin is growing in popularity as a supplement to improve hair, skin and nails. Yet biotin may interfere with some lab tests, including cardiac ones, potentially leading to false-positive or false-negative results. Having an accurate picture of a patient's cardiac risk can help physicians ensure that each patient is getting the correct treatment.

The High Sensitive Troponin-I test is now available to be used on Abbott's Architect system for cardiac risk assessment in CE marked countries and in countries where regulatory registration is not required for this product.

For more information: www.abbott.com

References:

1. Cardiovascular Diseases Fact Sheet. World Health Organization, May 2017. Web site: http://www.who.int/news-room/fact-sheets/detail/cardiovascular-diseases-(cvds).
2. Roques F et al. Eur Heart J. 2003 May;24(9):882-3.
3. Sigurdardottir FD et al. Am J Cardiol. 2018;121(8):949-955. https://doi.org/10.1016/j.amjcard.2018.01.004
4. Ford I et al. J Am Coll Cardiol. 2016; 68(25) 2719-2728.
5. Blankenberg S et al. Eur Heart J. 2016 Aug 7;37(30):2428-37.
6. Omland T et al. Clin Chem. 2015 Apr;61(4):646-56.
7. Everett et al. Circulation. 2015; 131(21):1851-1860.
8. Shah, Anoop SV et al. BMJ. 2015;350:g7873.