BioCentury
ARTICLE | Clinical News

Architect Stat High Sensitive Troponin-I Assay regulatory update

May 26, 2014 7:00 AM UTC

The U.K.'s NICE issued draft guidance recommending the Elecsys Troponin T high-sensitive assay from Roche (SIX:ROG; OTCQX:RHHBY, Basel, Switzerland) and the Architect Stat High Sensitive Troponin-I assay from Abbott for the early rule out of non-ST-segment elevation myocardial infarction (NSTEMI) in people presenting to an emergency department with chest pain and suspected acute coronary syndrome. NICE recommended the Access AccuTnl+3 troponin I assay from the Beckman Coulter Inc. subsidiary of Danaher Corp. (NYSE:DHR, Washington, D.C.) for research-use only in the indication due to a lack of evidence of its diagnostic accuracy. Comments on the guidance are due June 10, with a second committee meeting scheduled for June 24. ...