Venaxis, Inc. (Nasdaq: 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, today announced that 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 (FDA).
Steve Lundy, President and CEO of Venaxis, stated, "We are highly encouraged by the positive results from our pivotal clinical study, and I would like to thank all of our clinical partners and staff for the excellent work on this pivotal trial and submission. We look forward to working collaboratively with the FDA as they review our submission."
In its pivotal U.S. clinical study, the APPY1 Test performed with negative predictive value (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 clinical study protocol objectives and the results from Venaxis' previous pilot study.