Abbott has secured CE mark for its High Sensitive Troponin-I blood test, which will help predict the chance of heart attack or other cardiac event in healthy adults potentially months to years in advance.
Image: Abbott has secured CE mark approval for High Sensitive Troponin-I blood test to predict chance of heart attack. Photo: courtesy of Abbott.
The high sensitive Troponin-I blood test is claimed to be the first CE-marked troponin test that can predict the chance of heart attack or other cardiac event potentially months to years in advance in healthy people.
The blood test can be carried out on Abbott’s Architect system for cardiac risk assessment in countries accepting CE mark and other countries that does not require regulatory registration.
Abbott’s new diagnostic test uses a biomarker specific to the heart, helping doctors to identify people at risk for developing heart disease.
A significant body of research demonstrated that measuring a person’s troponin levels using high sensitive Troponin-I test offers better predictive information to determine person’s chances of developing future heart disease when added to the current standard of care.
Troponin-I proteins, which are released from the heart, can be found at elevated levels in the blood when the heart muscle has been damaged due to lack of blood flow.
Since last five years, the Architect Stat high sensitive Troponin-I blood test has been utilized in emergency rooms across Europe to enable physicians for rapid and accurate detection of heart attacks, particularly in women with lower troponin levels.
The high sensitive Troponin-I test is said to detect very low levels of troponin, and now it can be used to determine cardiac risk in people with no reported symptoms of heart disease.
Doctors can determine their patients’ risk of developing heart disease by using this diagnostic test during the same blood draw of a routine health exam, enabling to prevent unnecessary testing, medication and costs for lower-risk patients.
Abbott said using the diagnostic test during the same blood draw of a routine health exam will allow doctors to look at what’s actually happening to the heart and better identify their patients’ risk of developing heart disease, such as a heart attack or other cardiac event, in the future.
Abbott diagnostics business’ global medical and scientific affairs senior medical director Agim Beshiri said: “We finally have a heart-specific tool when trying to determine a patient’s chances of developing heart disease.
“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.”