Venaxis is a Colorado-based in vitro diagnostic company focused on developing and commercializing its unique multi-biomarker diagnostic test, the APPY1 Test. 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.
Diagnostic CT imaging can be effective, however it is very expensive and there are significant long-term health hazards associated with exposure to ionizing radiation, particularly for pediatric and adolescent patients, who have the highest risk for appendicitis. In many cases where diagnostic imaging is limited, patients are admitted to the hospital to avoid the risk of appendicitis rupture at home, which adds significant risk to the patient and cost for both the patient and the hospital. With a simple rapid blood test, the APPY1 Test, following FDA clearance or approval, physicians will have an additional tool to aid them in identifying patients at low risk for acute appendicitis potentially allowing for more conservative patient management, including reducing the number of CT scans and decreasing the patient length of time spent in the hospital and related costs .
The APPY1 Test is designed to run on Venaxis’ proprietary APPY Reader instrument. The APPY1 Test and APPY Reader received CE Mark in January 2013 and are being launched in the European market in Q1 of 2013. The test is also being evaluated in a pivotal clinical study in the United States, which is expected to conclude in Q4, 2013.