Venaxis files APPY1 test for Appendicitis with FDA - Venaxis

Venaxis has announced that it has filed a 510(k) premarket submission with the FDA for the APPY1 Test, a rapid, multiple biomarker-based index assay for identifying patients that are at low risk for Appendicitis.

In its pivotal US 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.

The test received CE mark approval in the EU in 2013. While FDA clearance is being sought, a limited commercial launch for the APPY1 Test is ongoing in select European countries.