Abbott Receives CE Mark for First Troponin Test to Help Predict the Chance of Heart Attack in Apparently Healthy Adults Potentially Months to Years in Advance

- Research shows adding Abbott's High Sensitive Troponin-I diagnostic test to doctors' existing standard of care can help more accurately determine a person's chances of a heart attack or other cardiac event potentially months to years in advance

- Physicians now have a blood test that looks at a biomarker from the heart, so people can confidently take the appropriate lifestyle and medical steps needed to help prevent heart disease

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Abbott

Sep 26, 2018, 18:01 ET

ABBOTT PARK, Ill., Sept. 26, 2018 /PRNewswire/ -- 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. To help people take control of their heart health, Abbott (NYSE: ABT) today announced that its High Sensitive Troponin-I blood test 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.

This life-changing 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 Dr. 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."

ADDRESSING HEART DISEASE: A SHIFT FROM DIAGNOSIS TO PREVENTION

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.

"We finally have a heart-specific tool when trying to determine a patient's chances of developing heart disease," said Agim Beshiri, M.D., senior medical director, global medical and scientific affairs for Abbott's diagnostics business. "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."

GETTING TO THE HEART OF HEALTHCARE: ACCURATE AND TIMELY DIAGNOSIS

In addition to more accurately determining a patient's cardiac risk, Abbott's High Sensitive Troponin-I test is designed so that biotin doesn't 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.

ABOUT CARDIOVASCULAR DISEASE¹Cardiovascular diseases are the leading cause of death globally. An estimated 17.7 million people globally die annually from cardiovascular diseases, according to the World Health Organization. Of those, 7.4 million were due to coronary heart disease. September 29 is World Heart Day, a global initiative that encourages people to take steps to prevent and control heart diseases. This year's theme is focused on looking after your own heart and the hearts of loved ones.

About Abbott:
At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world – in nutrition, diagnostics, medical devices and branded generic pharmaceuticals – that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

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References:

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