Friday, January 30, 2015
Venaxis, Inc., an in vitro diagnostic company focused on advancing commercialization of its CE Marked APPY1™ Test, a rapid blood test for aiding in identifying children, adolescent, and young adult patients in the emergency room who are at low risk for appendicitis, today announced the United States Food and Drug Administration (“FDA”) has determined that the APPY1 Test does not meet the criteria for substantial equivalence based upon data and information submitted by Venaxis in its 510(k) submission.
Steve Lundy, President and CEO of Venaxis, stated, “This FDA decision is very disappointing. The FDA provided us with a comprehensive description of the issues that led to its decision. We are in the process of reviewing all aspects of the FDA letter communication and evaluating, with our advisors, alternatives available to us. Such alternatives include continuing to seek U.S. regulatory approval for APPY1, exploring study protocols to address matters identified by the FDA, assessing the acceleration of our APPY2 next generation product and pursuing our commercial advances being made in Europe. We believe that the strong clinical trial results we achieved and the additional clinical utility information we provided to the FDA in responses to its requests for additional information were compelling, and we intend to continue to work with the FDA to advance the progress of a blood-based diagnostic test to assist in the evaluation of appendicitis.”
Source : http://venaxis.com/
