Positive topline results for APPY1 Test for Appendicitis - Venaxis

Venaxis has announced positive top-line results from its pivotal US study of its CE Marked APPY1 Test, a rapid, 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. In the measure of negative predictive value (NPV), which is the primary metric for the APPY1 Test, the results were 97.3%, with a lower 95% confidence limit of 95.5%. Additionally, the APPY1 Test performed with sensitivity of 96.9% (lower 95% confidence limit of 94.9%).

Specificity for APPY1 was 37.8% (lower 95% confidence limit of 35.3%), which is believed to be adequate for an adjunctive, negative predictive test such as the APPY1 Test. Overall prevalence of appendicitis was 25%, which was also in line with expectations and the medical literature. 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.