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Venaxis Inc announces positive top-line results from pivotal study of APPY1 test

Thursday, 13 Mar 2014 07:00am EDT 

Venaxis Inc:Positive top-line results from its pivotal U.S. study.Focused on obtaining FDA clearance for and commercializing its CE Marked APPY 1(tm) Test, a rapid, multiple biomarker-based assay for identifying patients that are at low risk for appendicitis.APPY 1 Test performed well, with sensitivity and negative predictive value results that exceeded those from previous pilot study.Company believes these pivotal results are sufficient for potential FDA clearance and expects to finalize its 510(k). 

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-0.024 -8.30%
5 Feb 2016