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August 11, 2014
08:12 EDTAPPYVenaxis annonces regulatory and market development progress
Venaxis announced previously that its FDA submission for the APPY Test had been filed with the U.S. Food and Drug Administration and that the FDA had reviewed the submission and provided Venaxis with an Additional Information request. Under the FDA's Submission Issue Meeting procedure, Venaxis also requested clarification from the FDA on certain of its feedback contained in the AI request. Today, Venaxis is reporting the current status of its FDA submission. The FDA has clarified the scope of the additional data requested to complete the supplemental filing to the submission package. Venaxis is in the process of compiling these data, revising its submission to address the FDA feedback, and plans to fully comply with the FDA's AI request. Based on an initial analysis of the scope of work required to completely respond to FDA feedback, Venaxis anticipates submission of the supplemental filing in Q4 of this year.
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October 27, 2014
18:26 EDTAPPYOn The Fly: After Hours Movers
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16:38 EDTAPPYVenaxis up 3% following presentation of APPY1 trial data
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16:37 EDTAPPYVenaxis presents APPY1 trial results
Venaxis announced the company's pivotal APPY1 Test clinical trial data were presented at the American College of Emergency Physicians Scientific Assembly 2014. The clinical trial involved 29 U.S. hospital sites recruiting patients aged 2 20 from January 2013 through January 2014. Results were presented by Lead Principal Investigator Dr. David S. Huckins, M.D. 1887 patients aged 2 to 20 years with suspected acute appendicitis were included in the study. The results of the study showed the APPY1 Test exhibited a sensitivity of 96.9%, a negative predictive value of 97.3%, a negative likelihood ratio of 0.08, and a specificity of 37.8% for acute appendicitis. Prevalence of disease was 25.3%. The APPY1 Test correctly identified 533 of 1409 patients who did not have appendicitis with 15 false negatives among 478 patients with acute appendicitis. Among patients without appendicitis, 32% who underwent a computed tomography were correctly identified by negative APPY1 Test results. The APPY1 Test is under FDA review and is currently not available for sale in the U.S.

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