The European Union has granted CE mark approval to Venaxis's blood-based test which is designed to identify patients at low risk for acute appendicitis.
The APPY1 test, which is being initially developed for pediatric, adolescent and young adult patients with abdominal pain, will be made available in the first quarter of 2013 in selected European territories including the UK, Italy, France, Germany and Benelux.
Venaxis president and CEO Steve Lundy said to expand the commercialization of the test, the company has initiated the next critical phase of its 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," Lundy added.
"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."