BioCentury
ARTICLE | Clinical News

Venaxis reports pivotal data for appendicitis diagnostic

March 13, 2014 11:39 PM UTC

Venaxis Inc. (NASDAQ:APPY) said its APPY1 Test had a negative predictive value (NPV) of 97.3% for identifying patients at low risk for appendicitis in the pivotal U.S. CP-12 trial. The test also had 96.9% sensitivity and 37.8% specificity, which Venaxis said "is believed to be adequate for an adjunctive, negative predictive test such as the APPY1 Test." The trial enrolled 1,887 patients that presented in the hospital emergency department with abdominal pain with suspicion of appendicitis and who had blood drawn as part of their normal work-up.

Venaxis plans to submit a 510(k) application to FDA for APPY1 Test "in the next few weeks." The test already has CE Mark approval and is available in select European countries. APPY1 Test is a multi-marker, blood-based test panel consisting of the S100 calcium binding protein A8 ( S100A8; calgranulin A; MRP8) and MRP14 biomarkers and C-reactive protein (CRP), plus a white blood cell count. ...