Abbott Receives CE Marking for Architect Stat High Sensitive Troponin-I Assay

From the wire: Abbott announced today CE marking for the Architect Stat High Sensitive Troponin-I assay, which may allow doctors to evaluate whether or not patients are having a heart attack within two to four hours. An estimated 17 million people throughout the world die annually of cardiovascular diseases, specifically heart attacks or strokes, according to the World Health Organization. Time is a critical factor in diagnosing and treating people who may be having a potential heart attack. Many patients who visit the emergency room with chest pain complaints and a suspected heart attack currently have blood samples drawn for troponin tests upon admission, after six hours, and then potentially 12 hours later before a diagnosis may be made.
 
Abbott’s new Architect Stat High Sensitive Troponin-I assay can measure very low levels of the protein and allow doctors to reduce the time to diagnosis and treatment by several hours when compared with standard troponin tests.

"The advantage of high sensitive troponin tests compared to current tests is that clinicians may now more precisely confirm or exclude a heart attack much sooner and with higher accuracy compared to contemporary tests," said Professor Stefan Blankenberg, director of cardiology at the University Heart Center of Hamburg, Germany. "This is important information for patient care because we can pursue treatment if needed or avoid invasive therapy and discharge a patient earlier."

Another concern for patients who have experienced symptoms of a heart attack or who suffered from an actual attack is that they are at a higher risk for experiencing a second cardiac event or heart attack within a few weeks or months. Abbott’s assay also enables doctors to determine if patients are at risk to suffer from cardiovascular events 30 days and 90 days later.
 
The new assay runs on Abbott’s fully-automated Architect family of analyzers and is available in CE-marked and nonregulated countries, pending country registration.