Abbott has reported positive preliminary results from a study evaluating its Architect Stat High Sensitive Troponin-I (hsTnI) assay at the European Society of Cardiology (ESC) Congress 2013.
Results suggest that its high-sensitive troponin test may help doctors improve the diagnosis and prognosis of patients with symptoms of a heart attack.
Women in particular who exhibit different symptoms and are often under-diagnosed could benefit from this test.
Abbott’s hsTnI test can also measure very low levels of Cardiac troponin, a protein found in the heart muscle, and a preferred biomarker to identify suspected heart attacks.
This unique feature especially benefits women as they often have lower levels of troponin than men.
University of Edinburgh key study authors and cardiologist Dr Nicholas Mills said that by using the Abbott high sensitive troponin test and different diagnostic thresholds for men and women, the frequency of diagnosis of heart attacks in women increased and was comparable with men.
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“The findings of our study, when completed, could change the way we diagnose heart attacks in women, potentially reducing inequalities in the treatment and outcomes, and enabling everyone to receive the best care,” Dr Mills said.
University of Edinburgh researchers reported the clinical data from the first 1,126 patients of the study at ESC Congress 2013.
This study is expected to complete in 2016 and will enrol more than 25,000 patients across ten centres in Scotland alone. The study was funded under a special project grant from the British Heart Foundation, while Abbott provided the Architect Stat hsTnI assay.
Abbott diagnostics research divisional vice-president Dr John Frels noted that while Abbott’s high sensitive troponin test benefits both men and women with earlier detection of heart attacks, the potential to increase the diagnosis among women is especially important.
“This is the first time we have seen a test that can provide this kind of detailed information to doctors and has the potential to aid doctors with improving the odds of survival for women with heart attacks,” Dr Frels said.
The Architect Stat hsTnI assay received CE Mark approval in January 2013 and is currently available in Australia, Brazil, Canada and New Zealand.
The test runs on Abbott’s fully automated Architect family of analysers and is currently available for research-use only in the US.
According to GlobalData estimates, cardiac markers market in the US was valued at $235m in 2012 and is expected to grow at CAGR of 6.6% to reach $368m by 2019.