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Abbott (ABT) Gets FDA Nod for New Troponin-I Blood Test

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Abbott Laboratories ABT recently attained the FDA approval for its ARCHITECT STAT High Sensitivity Troponin-I blood test. This is one of the most meticulously-researched troponin diagnostic tests, which can now be utilized to diagnose heart attacks in a swifter and more accurate method than contemporary troponin tests.

The integration of Abbott's high sensitivity troponin-I assay to the laboratory's diagnostic testing menu is a major stride forward in the company’s commitment toward detecting patients suspected of having a heart attack. Encouragingly, this FDA clearance is expected to boost its Diagnostics business segment.

More About the Blood Test

Abbott's High Sensitivity Troponin-I blood test is equipped to measure very low levels of troponin, allowing doctors to determine heart attack in patients within two to four hours of admission. Women are expected to particularly benefit from this new technology as they mostly have lower levels of troponin than men, which make them more susceptible to undiagnosed heart attacks with contemporary troponin tests. 

This high-sensitivity assay has been proved to diagnose a heart attack earlier. This could help hospitals with swifter management of those diagnosed with a heart attack, as well as ensure safe and early discharge of patients, resulting in savings for the healthcare system.

With this FDA clearance, the blood test may be sold in the United States for use on Abbott's fully-automated ARCHITECT analyzer. The ARCHITECT STAT High Sensitivity Troponin-I outcomes should be used in combination with other diagnostic information such as electrocardiogram (ECG), clinical observations and information, and patient symptoms to help in the detection of heart attacks.

Market Prospects

The heart attack diagnostics market is projected to reach $15.4 billion by 2024, according to a new report by Grand View Research. Hence, this FDA approval comes at an ideal time.

Recent Developments

Lately, Abbott has been focusing on strengthening the Diagnostics business segment.

In August 2019, the company announced favorable results from its new study, the Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI). The study highlighted that elevated levels of protein measured with the company's blood test (currently under development) can aid in the diagnosis of mild traumatic brain injuries (TBIs), even when a CT scan cannot detect it. This outcome should be a crucial step toward the company’s endeavors to boost TBI diagnosis and treatment.

In July 2019, Abbott announced FDA approval for its new blood and plasma screening Alinity s System. This new solution is expected to bring the most innovative screening technology to U.S. blood and plasma centers. Alinity s has been designed for more efficient screening of blood and plasma within a smaller space compared with commercially available competitive systems. 

Major Peers Working on Troponin-I

Some major medical device companies posing competitive threat to Abbott in the field of developing troponin blood diagnostic tests are Baxter BAX, Boston Scientific BSX and Bio-Rad Laboratories BIO.

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