Product News: Venaxis Obtains CE Mark for APPY1 Appendicitis Test

18 Jan 2013

Venaxis, Inc., an in vitro diagnostic company, has announced it has fulfilled the requirements for CE Marking in Europe for APPY1, the Company's blood-based appendicitis test. Initial commercialization in Europe is planned to commence in the first quarter 2013 in key territories, including the UK, Italy, France, Germany and Benelux countries. The Company expects to announce agreements with top EU distributors beginning in the first quarter 2013.

Designed to aid in the identification of patients at low risk for acute appendicitis, the APPY1 Test is a simple, rapid blood test that may help physicians manage the large number of children and adolescents who enter hospital emergency departments with abdominal pain, suspected of acute appendicitis. Determining if a patient requires emergency surgery for appendicitis is critical and current practices have important limitations.

Steve Lundy, President and CEO of Venaxis, stated, "We are pleased to report this important accomplishment, which allows us to market APPY1 in Europe and initiate the next critical phase of our market development effort. This initial phase will involve finalizing agreements with selected distributors, working with those same distributors and placing APPY1 in the hands of select hospitals in each of our target European territories. Our strategy is to leverage the experience of these key opinion leader hospital sites over the first half of 2013 in order to generate meaningful, multinational data for APPY1 that will allow us to refine our approach to the broader EU market and prepare for full scale launch later in 2013. As we work in parallel to gain U.S. regulatory clearance, EU market development remains a top priority for Venaxis, and we believe this strategic approach will maximize our potential for increased market penetration and allow us to ramp sales quickly once those activities are completed."