Instrumentation Laboratory's blood clot test approved in US and Canada
This article was originally published in Clinica
Executive Summary
The US FDA has granted 510(k) clearance for Instrumentation Laboratory's HemosIL D-Dimer HS 500 assay. The test is designed to rule out venous thromboembolism in cases of suspected deep vein thrombosis and pulmonary embolism. Health Canada has also approved the product, which provides results in five minutes. It measures levels of D-dimer in patients' citrated plasma, a fragment present in the blood after a blood clot has broken down. Studies have found it has a 100% negative predictive value, Instrumentation Laboratory (Bedford, Massachusetts) claims. The firm will commercialise the test in the US with its distribution partner, Beckman Coulter. The assay was launched in Europe in April 2009.