Abbott’s Troponin-I blood test receives FDA clearance

26 September 2019 (Last Updated September 26th, 2019 12:01)

Abbott has received US Food and Drug Administration (FDA) clearance for its Architect Stat High Sensitivity Troponin-I blood test to diagnose heart attacks.

Abbott’s Troponin-I blood test receives FDA clearance
Measuring a person’s troponin levels using the Troponin-I blood test can help predict a person’s chances of having a cardiac event in advance. Credit: Lori Greig.

Abbott has received US Food and Drug Administration (FDA) clearance for its Architect Stat High Sensitivity Troponin-I blood test to diagnose heart attacks.

The blood test is said to detect heart attacks several hours earlier than conventional troponin tests, for a faster and more accurate diagnosis.

A troponin blood test is commonly used to diagnose individuals who visit an emergency room with a suspected heart attack. The levels of troponin-I proteins released from the heart are known to increase in the blood in case of heart muscle damage.

Abbott’s blood test is designed to measure low troponin levels and enable assessment of heart attack within two to four hours of admission.

The company expects that the Architect Stat High Sensitivity Troponin-I blood test will particularly help women, who have lower troponin levels than men.

Abbott Diagnostics global medical and scientific affairs senior medical director Agim Beshiri said: “This important milestone will allow US physicians to utilise the advanced, proven capabilities of this blood test as they evaluate patients suspected of a heart attack.

“As one of the most widely researched high sensitivity troponin tests, this technology could help address several challenges in emergency departments today, including overcrowding and more accurately identifying heart attacks in women.”

The blood test can be used on the company’s fully-automated Architect analyser and in conjunction with additional diagnostic information, including electrocardiogram (ECG), clinical observations and information and patient symptoms.

Abbott will initiate Heart Partnership Program in the US to help hospital care teams implement the blood test into their care pathway.

The blood test has been assessed in around 200 studies throughout Europe and Asia, where it is named High Sensitive Troponin-I.

In April, Abbott reported positive findings from a study, where the Troponin-I blood test was able to predict heart disease risks in those with no symptoms.