Venaxis' APPY1 Test for appendicitis shows positive results in pivotal U.S. study

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 assay for identifying patients that are at low risk for appendicitis, today announced positive top-line results from its pivotal U.S. study. The APPY1 Test performed well, with sensitivity and negative predictive value results that exceeded those from the previous pilot study. 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.

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.

Top line data statistics for the recently completed pivotal clinical study (CP-12) as compared to the prior pilot study (CP-11), are summarized as follows:  

Principal study investigator Dave Huckins, M.D., stated, "These top-line results reflect improved test performance for negative predictive value and sensitivity compared to Venaxis' previous 500-patient pilot study.  This is highly significant for a number of reasons.  In addition to involving many more hospital sites and patients, for the first time in this pivotal study the APPY1 Test was performed on-site in real time at each participating hospital, by hospital personnel, as the test would be run in the real clinical setting. The pivotal study also enrolled a more ethnically diverse patient demographic compared with the previous 500-patient pilot study.  The fact that the APPY1 Test performance matched, and even improved upon, the previous results in the face of these 'real world' factors adds significant robustness to the pivotal study results."

Steve Lundy, President and CEO of Venaxis™, stated, "The positive outcome from this study is a significant achievement for Venaxis, and I want to commend our team and our clinical partners on a very well-run study. Also of note, the APPY1 Tests used during the study were produced from multiple manufacturing lots, demonstrating their reproducibility. We are working now to complete our analysis of the data for inclusion into our 510(k) package to the FDA, which we expect to submit in the next few weeks.  While we await its review, our market development activities continue to accelerate not only in Europe, but also in in the United States, where we've begun collecting important hospital and physician market data and identifying hospitals that have significant influence and community outreach.  Our goal is to be well positioned for successful product launch upon potential FDA clearance of the APPY1 Test."