Abbott’s heart failure test given CE marking

Hannah Blake

pharmaphorum

Abbott has announced CE marking for its ARCHITECT Galectin-3 assay, which is a test to help doctors assess the prognosis of patients diagnosed with chronic heart failure. The test was developed in partnership with BG Medicine, to run on Abbott’s ARCHITECT immunochemistry platform.

The CE marking is the manufacturer’s declaration that the product meets the requirements of the European Commission and has been a mandatory conformity for products sold within the European Economic Area since 1993.

"Galectin-3 reflects the pathophysiology of heart failure and is one of the most powerful prognostic indicators in heart failure. It helps clinicians identify which patients are at high risk for worsening heart failure early in the course of their disease. Knowing which patients are at increased risk of hospital readmission – independent of other variables – could provide physicians with important information to help them reach different decisions about treatment, which may benefit patient care."

Dr. Rudolf de Boer, Associate Professor in Cardiology at the University Medical Centre Groningen, the Netherlands.

The test is available in several European countries.