Venaxis' APPY1 test shows positive top-line results Venaxis announced positive top-line results from its pivotal U.S. study of its CE Marked APPY1 Test, a multiple biomarker-based assay for identifying patients that are at low risk for appendicitis. The APPY1 Test performed well, with sensitivity and negative predictive value results that exceeded those from the previous pilot study. The company believes these pivotal results are sufficient for potential FDA clearance and expects to finalize its 510(k) submission and file with the FDA in the next few weeks.
Venaxis presents APPY1 trial results Venaxis announced the company's pivotal APPY1 Test clinical trial data were presented at the American College of Emergency Physicians Scientific Assembly 2014. The clinical trial involved 29 U.S. hospital sites recruiting patients aged 2 – 20 from January 2013 through January 2014. Results were presented by Lead Principal Investigator Dr. David S. Huckins, M.D. 1887 patients aged 2 to 20 years with suspected acute appendicitis were included in the study. The results of the study 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 patients who did not have appendicitis with 15 false negatives among 478 patients with acute appendicitis. Among patients without appendicitis, 32% 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 U.S.