Patient enrollment completed for Venaxis' pivotal clinical study of APPY1 Test

Jan 24 2014

Venaxis, Inc. (Nasdaq: APPY), an in vitro diagnostic company focused on obtaining FDA clearance 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 completion of patient enrollment in its pivotal clinical study of the APPY1 Test in the United States. Venaxis expects to announce top-line data following the required patient follow-up period and subsequent database lock and required analysis of the data. The study enrolled patients at approximately 27 hospital sites across the United States, and the pivotal data will be based on approximately 2,000 net evaluable patients.

Steve Lundy, President and Chief Executive Officer of Venaxis™, commented, "Completing this significant pivotal U.S. study is a major milestone for Venaxis and we look forward to reporting the data when it is available.  We will work to finalize our 510(k) and final data package for FDA submission at or near the end of the first quarter, assuming positive data.  In the meantime, we remain committed to our diligent market development efforts and expect to be well positioned to launch the APPY1 Test in the United States upon receipt of clearance."