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Venaxis’ APPY1 Test Passes Final Futility Analysis in Pivotal Clinical Study

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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, recently announced that the external Data and Safety Monitoring Board (DSMB) created as part of the Company’s pivotal clinical trial for the APPY1 Test has recommended continuation of the pivotal clinical trial, based upon completion of the second and final futility analysis included in the clinical trial design.

The futility analysis, which consisted of an independent review of the validity, integrity, and clinical and scientific relevance of the ongoing study, was performed on the first 1,061 patients to complete the study. On July 15, 2013, Venaxis® announced that the study would continue following a previous futility analysis performed on the first 579 patients to complete the study. The pivotal study will enroll a total of 2,000 evaluable patients, of which approximately 1,300 have been enrolled to date. Venaxis is on track to complete enrollment as guided by the end of 2013.

Steve Lundy, President and CEO of Venaxis, stated, “Since initiating patient enrollment in our pivotal study earlier this year, we have focused significant effort on meeting our recruitment goals. We’ve worked closely with our clinical sites and enhanced our approach along the way, and through those efforts we have been successful in ramping our enrollment rates efficiently. Further encouraged by the DSMB’s final recommendation to complete the trial as designed, we continue to anticipate enrollment completion by the end of 2013, and subject to the clinical trial results, file for FDA clearance in the first quarter 2014.”

Source: PR Newswire