BioCentury
ARTICLE | Clinical News

BRAHMS Copeptin blood test regulatory update

March 21, 2011 7:00 AM UTC

The U.K.'s NICE issued an appraisal consultation document recommending against use of Thermo Fisher's BRAHMS copeptin assay in combination with cardiac troponin testing to rule out myocardial infarction (MI) in patients presenting with acute chest pain. According to the independent Medical Technologies Advisory Committee (MTAC), while the assay shows the potential to reduce time needed to rule out MI, more evidence on its impact on clinical practice and on time saved is needed to support its routine adoption by the NHS. NICE noted that trials of the assay did not evaluate the time taken to discharge patients and the time taken for patients to receive access to appropriate treatment. The agency said additional trials of the assay are needed to support adoption of the BRAHMS assay on the NHS. The deadline for comments is April 4, with a second appraisal committee meeting scheduled for April 20. ...