diaDexus Inc. has launched CE-marked PLAC Test for Lp-PLA(2) Activity in Europe. The PLAC Activity test will be sold in Europe to clinical and hospital laboratories through a network of 11 distributors. The PLAC Test for Lp-PLA(2) Activity is an easy-to-perform blood test designed to be used in conjunction with clinical evaluation and patient risk assessment as an indicator of atherosclerotic cardiovascular disease.
The new PLAC Test for Lp-PLA(2) Activity will be used by healthcare professionals to identify the hidden risk of cardiovascular events that are missed by traditional risk factors, such as cholesterol levels, blood pressure, family history and smoking. Physicians in Europe may request the PLAC Test for Lp-PLA(2) Activity for patients with two or more cardiovascular risk factors.
A meta-analysis published in 2010 in The Lancet by the Lp-PLA(2) Studies Collaboration that included data from approximately 58,000 patients from 18 previously published studies confirmed that Lp-PLA(2) levels are significantly related to cardiovascular disease risk. Cardiovascular heart disease is the first cause of mortality in Europe resulting in 4.3 million deaths each year. In 2011, diaDexus initiated a comprehensive outreach and physician education program, including scientific and clinical presentations at both the European Stroke Association and the European Society for Cardiology meetings. The outreach efforts have highlighted that circulating levels of the enzyme are associated with increased risk of atherosclerotic cardiovascular disease, and now it will be possible for Lp-PLA(2) testing to be more widely available throughout Europe.
“We will continue collaborating with key opinion leaders in each European country to work toward publication of medical practice guidelines to support Lp-PLA(2) assessment as part of both regular annual medical checkups as well as certain hospital-based cardiovascular assessment programmes,” said Brian E Ward, chief executive officer. “While we expect a modest contribution to 2012 revenue from European sales, we expect greater contributions to revenue as awareness increases and reimbursement coverage is secured in key European countries, such as Germany, France and the United Kingdom.”
The PLAC Test for Lp-PLA(2) Activity measures the enzymatic activity of Lp-PLA(2), a vascular specific inflammatory enzyme that is produced in rupture prone plaques. The PLAC Test for Lp-PLA(2) Activity can be performed on easy-to-use clinical chemistry analyzers that are found in clinical and hospital laboratories. In addition, the PLAC Test for Lp-PLA(2) Activity specimen collection and preparation are not difficult, making the PLAC Test for Lp-PLA(2) Activity easy to prescribe and perform.
diaDexus Inc. is focused on the development and commercialization of patent-protected in vitro diagnostic products addressing unmet needs in cardiovascular disease.