ABBOTT PARK, Ill., Sept. 25, 2019
/PRNewswire/ -- Abbott (NYSE: ABT) today announced that its
ARCHITECT STAT High Sensitivity Troponin-I blood test has received
clearance from the U.S. Food and Drug Administration (FDA). As one
of the most researched troponin diagnostic tests, doctors in the
U.S. can now utilize this proven technology to help detect heart
attacks faster and more accurately than contemporary troponin
tests.
Transforming cardiac disease diagnosis
An estimated 840,000 Americans die of cardiovascular diseases
each year.1 Even as cardiovascular care advances, heart
disease remains the leading cause of death.1 Timing is a
critical factor in helping doctors diagnose and treat those having
a potential heart attack.
When people enter the emergency room with a suspected heart
attack, doctors typically use a troponin blood test to help aid in
their diagnosis. 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. Abbott's High Sensitivity Troponin-I blood
test measures very low levels of troponin, allowing doctors to
evaluate heart attack in patients within two to four hours of
admission.
Women may particularly benefit from this technology as they
often have lower levels of troponin than men, which could lead to
an undiagnosed heart attack with contemporary troponin tests.
2
"The addition of Abbott's high sensitivity troponin-I assay to
the laboratory's diagnostic testing menu is a great step forward to
help laboratory scientists and clinicians better evaluate patients
suspected of having a heart attack," said Fred Apple, Ph.D., co-director of Clinical and
Forensic Toxicology Laboratory at Hennepin Healthcare/Hennepin
County Medical Center and professor, Laboratory Medicine and
Pathology at the University of
Minnesota.
"Our research using this high sensitivity assay has demonstrated
it can provide doctors with the ability to detect or rule out a
heart attack earlier. This ability could help hospitals with more
rapid triage and management of those diagnosed with a heart attack,
as well as being able to safely discharge patients earlier on,
resulting in savings to the healthcare system."
Robust body of evidence supports Abbott's highly sensitive
troponin-I test
Abbott's blood test, known as High Sensitive Troponin-I in
Europe and Asia, has been used throughout hospitals
internationally and researched in more than 200 studies for its
role in identifying heart disease and cardiac events,
including:
- Abbott's High Sensitive Troponin-I test was the first test
outside of the U.S. to offer gender-specific cut-offs, allowing
physicians to more accurately diagnose heart attacks in women. A
study published in the British Medical Journal found Abbott's test
uncovered twice as many heart attacks in women than standard
troponin tests.2
- A study published in The Lancet found the test may help doctors
rule out heart attack sooner for two-thirds of patients who were
suspected of having a heart attack.3 This allows doctors
to discharge patients more quickly and avoid unnecessary further
testing.
- Research in the Journal of the American Medical Association
(JAMA) found that detecting a change in troponin levels using the
high sensitivity test over the first three hours after admission
could facilitate an early diagnosis of heart
attacks.4
Doctors can also be confident in the results they receive
because Abbott's core laboratory diagnostic tests, including our
troponin test, are by design not affected by biotin interference.
Biotin is growing in popularity as a supplement that people believe
may improve hair, skin and nails. Recently, the FDA alerted the
public and medical community that biotin can significantly alter
some lab test results, including some cardiac tests.
"This important milestone will allow U.S. physicians to utilize
the advanced, proven capabilities of this blood test as they
evaluate patients suspected of a heart attack," said Agim Beshiri, M.D., senior medical director,
global medical and scientific affairs, Diagnostics, Abbott. "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."
As U.S. hospitals are beginning to use high sensitivity troponin
blood tests, education and collaboration among emergency room
physicians, lab clinicians and cardiologists are critical. To help
with this effort, Abbott will be introducing the Heart Partnership
Program. The new program will help hospital care teams implement
the blood test into their care pathway – including utilizing
technologies that can automate the process – and use the test
results to help diagnose patients and better inform treatment
plans.
With this clearance, the blood test may be sold in the U.S. for
use on Abbott's fully-automated ARCHITECT analyzer. The ARCHITECT
STAT High Sensitivity Troponin-I results should be used in
conjunction with other diagnostic information such as
electrocardiogram (ECG), clinical observations and information and
patient symptoms to aid in the diagnosis of heart attacks.
About Abbott:
Abbott is a global healthcare leader
that helps people live more fully at all stages of life. Our
portfolio of life-changing technologies spans the spectrum of
healthcare, with leading businesses and products in diagnostics,
medical devices, nutritionals and branded generic medicines. Our
103,000 colleagues serve people in more than 160 countries.
Connect with us at www.abbott.com, on LinkedIn at
www.linkedin.com/company/abbott-/, on Facebook
at www.facebook.com/Abbott and on Twitter @AbbottNews and
@AbbottGlobal.
References:
- Heart Disease and Stroke Statistics – 2019 Update. A Report
from the American Heart Association. Circulation.
March 5, 2019. Website:
https://www.ahajournals.org/doi/pdf/10.1161/CIR.0000000000000659.
- Shah A et al. BMJ. 2015;350:g7873.
- Shah A et al. Lancet 2015;386(10012):2481-88.
- Keller T et al. JAMA. 2011;306(24):2684-93.
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SOURCE Abbott