EU approves APPY1 test (Venaxis) for patients at low risk for acute Appendicitis

The EU has given CE Mark approval to the APPY1 blood-based Appendicitis test, from Venaxis. The unique test is designed to aid in the identification of patients at low risk for acute Appendicitis, allowing for more conservative patient management. APPY1 is being developed initially for pediatric, adolescent and young adult patients with abdominal pain, as this population is at the highest risk for Appendicitis and has the highest risk of long-term health effects associated with CT imaging.

The company has also begun enrolling patients into its pivotal clinical study in the US. Based on current enrollment expectations, the Company anticipates completing the study in six to eight months and filing with the FDA for regulatory clearance of APPY1 in the fourth quarter 2013. 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.