FDAnews Device Daily Bulletin

AXIS-SHIELD ANNOUNCES LAUNCH OF FIRST ASSAY UNDER AXSYM XTRA PROGRAMME

June 1, 2006
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Axis-Shield, the international in vitro diagnostics company, today announces the launch of a test for D-dimer to run on the widely-placed AxSYM automated immunoassay system marketed by Abbott Laboratories. D-dimer is an important blood coagulation marker which is raised in deep vein thrombosis (DVT) and pulmonary embolism (PE). These are serious and relatively common clotting conditions that contribute to patient morbidity and mortality, with substantial costs to healthcare systems in the developed world, where the incidence is around 1:1000. The AxSYM D-dimer test has a negative predictive value greater than 98%, giving it high utility in ruling out DVT and PE.
Axis-Shield