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Venaxis Reports on Recent FDA Submission Activities
Date:7/16/2014

CASTLE ROCK, Colo., July 16, 2014 /PRNewswire/-- Venaxis, Inc. (Nasdaq: APPY), an in vitro diagnostic company focused on obtaining FDA clearance for and commercializing its CE Marked APPY1™ Test, a rapid, multi-analyte assay for aiding in identifying children, adolescent and young adult patients that are at low risk for appendicitis, updated on recent activities concerning its U. S. Food and Drug Administration (FDA) submission for the APPY1 Test that was filed in March 2014. The FDA has reviewed the submission, and provided Venaxis with questions and information requests on the submission.      

Venaxis is compiling responses to the FDA's questions and their requests for additional data and information, as well as seeking clarification from the FDA on certain of its requests. Under the FDA's Submission Issue Meeting procedures, we expect a meeting in the upcoming weeks to discuss the items on which we seek clarification.     

Steve Lundy, President and CEO of Venaxis, stated, "We are encouraged by the FDA's responsiveness to our filing and look forward to working collaboratively with the FDA to complete the review process."

About Venaxis, Inc.
Venaxis, Inc. is an in vitro diagnostic company focused on the clinical development and commercialization of its CE Marked APPY1 Test, the Company's rapid, multi-analyte assay for appendicitis. This unique appendicitis test has projected high sensitivity and negative predictive value and is being developed to aid in the identification of patients at low risk for acute appendicitis, allowing for more conservative patient management. The APPY1 Test is being developed initially for pediatric, adolescent and young adult patients with abdominal pain, as this population is at the highest risk for appendicitis and has the highest r
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SOURCE Venaxis, Inc.
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