The U.S. Food and Drug Administration cleared Abbott’s blood test to help aid in the diagnosis of heart attacks for men and women hours earlier than standard tests and marks significant progress for detecting heart attacks in women.
The U.S. Food and Drug Administration (FDA) cleared Abbott’s blood test to help aid in the diagnosis of heart attacks for men and women hours earlier than standard tests and marks significant progress for detecting heart attacks in women.
This morning, Abbott said the FDA cleared its ARCHITECT STAT High Sensitivity Troponin-I blood test, which will be more accurate than current troponin tests that are in use. In the United States, heart disease is the leading cause of death with an estimated 840,000 disease-related deaths annually. Currently, when patients enter the emergency room with a suspected heart attack, a troponin blood test is used to aid in the diagnosis. When heart muscles are damaged, elevated levels of troponin-I proteins can be found in the blood. Abbott’s high sensitivity test measures very low levels of troponin, allowing doctors to evaluate heart attack in patients within two to four hours of admission. The blood test had previously been cleared for use in Europe.
The newly-cleared test is viewed as especially important for women. Heart attack attacks in women are often misdiagnosed, and less likely than men to receive aggressive diagnosis and treatment for cardiovascular disease, Abbott said in its announcement this morning. Women typically have lower levels of troponin protein than men and tests have shown that the Abbott blood test can uncover twice as many heart attacks in women as standard troponin tests. Also, women are more likely to experience different heart attack symptoms than men, such as spontaneous shortness of breath or sweating or pain in the neck, Abbott said. The new test should be able to lead to delays in treatment or women being discharged without a diagnosis.
Agim Beshiri, senior medical director of global medical and scientific affairs of Abbott’s diagnostics unit, called the clearance an “important milestone” in heart attack treatment. Beshiri said the clearance will allow physicians to use the “proven capabilities” of the blood test to evaluate patients suspected of having 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,” Beshiri said in a statement.
Study data leading up to the FDA clearance found the test may help doctors rule out heart attack sooner for two-thirds of patients who were suspected of having a heart attack. This allows doctors to discharge patients more quickly and avoid unnecessary further testing, Abbott said. Additionally, the company noted that data showed 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
Fred Apple, co-director of Clinical and Forensic Toxicology Laboratory at Hennepin Healthcare/Hennepin County Medical Center, said 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.”
“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,” Apple said.
