Pivotal trial data on APPY1 Test for Appendicitis-Venaxis

Venaxis's pivotal APPY1 Test clinical trial data for acute Appendicitis were presented at the American College of Emergency Physicians Scientific Assembly 2014. The results showed the APPY1 Test exhibited a sensitivity of 96.9%, a negative predictive value of 97.3%, a negative likelihood ratio of 0.08, and a specificity of 37.8% for acute Appendicitis. Prevalence of disease was 25.3%.

The APPY1 Test correctly identified 533 of 1409 (37.8%) patients who did not have appendicitis with 15 (3.1%) false negatives among 478 patients with acute appendicitis. Among patients without appendicitis, 32% (136/431) who underwent a computed tomography were correctly identified by negative APPY1 Test results. The APPY1 Test is under FDA review and is currently not available for sale in the US. Results were presented by Lead Principal Investigator Dr. David S. Huckins, M.D.