Cholestech gets US thumbs-up for CRP test:
This article was originally published in Clinica
Executive Summary
The US FDA has given Cholestech 510(k) market clearance to add a high sensitivity C-reactive protein (hs-CRP) blood test to the menu of assays run on its LDX tabletop analyser. The test, the first immunoassay developed for use on the analyser, can help doctors assess arterial inflammation and risk of heart disease. Laboratories will be able to use the test on the LDX system following the completion of a simple software upgrade, says the Hayward, California firm. Cholesterol and liver enzyme tests are already available for use on the analyser.