NEW YORK (360Dx) – Abbott announced today that its High Sensitive Troponin-I blood test has been CE marked.
The test is now available for use on the company's Architect system for cardiac risk assessment in countries that recognize the designation.
According to the Abbott Park, Illinois-based company, it is the first troponin test with CE marking that can more accurately predict — potentially months or even years ahead of time — whether a person may have a heart attack or other cardiac event. Research has demonstrated the test, when combined with current standards of care, "provides better predictive information for determining a person's chances of developing future heart disease," Abbott said.
The High Sensitive Troponin-I test uses the same blood draw of a routine health exam and was designed to be unaffected biotin, which has grown in popularity as a vitamin supplement, but may interfere in some lab tests, including cardiac tests.
While troponin tests have been in use in Europe for years, they have been cleared in the US only recently. Roche received US Food and Drug Administration clearance for its test in early 2017, while Beckman Coulter's troponin test was cleared this past June. Siemens received clearance for its test the same month.
The Abbott test is pending clearance from the FDA, a spokesperson said.