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March 13, 2014
07:10 EDTAPPYVenaxis' APPY1 test shows positive top-line results
Venaxis announced positive top-line results from its pivotal U.S. study of its CE Marked APPY1 Test, a multiple biomarker-based assay for identifying patients that are at low risk for appendicitis. The APPY1 Test performed well, with sensitivity and negative predictive value results that exceeded those from the previous pilot study. The company believes these pivotal results are sufficient for potential FDA clearance and expects to finalize its 510(k) submission and file with the FDA in the next few weeks.
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