Venaxis Files For FDA Clearance Of APPY1 Test - Quick Facts

(RTTNews) - Venaxis, Inc. (APPY), an in vitro diagnostic company focused on obtaining FDA clearance for and commercializing its CE Marked APPY1 Test, a rapid, multiple biomarker-based index assay for identifying patients that are at low risk for appendicitis, said it has filed a 510(k) premarket submission for the APPY1 Test. Venaxis has requested concurrent de novo determination and 510(k) clearance from the U.S. Food and Drug Administration or FDA.

In its pivotal U.S. clinical trial, the APPY1 Test performed with negative predictive value or NPV of 97.3%, which is the primary metric for the APPY1 Test, sensitivity of 96.9% and specificity of 37.8% on the target population. NPV and sensitivity are the key performance measures, and the results exceeded the study protocol objectives and the results from Venaxis' prior pilot study.