Drug maker Venaxis Inc (NASDAQ:APPY) reported top line results from its ongoing clinical trials of its diagnostic testing procedure designed to identify individuals who are prone to suffer from appendicitis. The tests were conducted on the “CE Marked APPY1 Test” returned data which indicated a highly sensitive test process which also provides a negative indicator of the presence of risk in individuals. The data relevancy was well above the expectations of the study team. The positive and overwhelmingly convincing data collected has convinced the test team that they can now confidently proceed to seek FDA clearance for their testing procedure.
CEO Commends His Team
Expressing his immense happiness at the highly favorable results from one of its flag ship target test procedure, Venaxis Inc (NASDAQ:APPY) President, Chief Executive Officer, Director Stephen T. Lundy has gone on record to state that, “The positive outcome from this study is a significant achievement for Venaxis, and I want to commend our team and our clinical partners on a very well-run study. Also of note, the APPY1 Tests used during the study were produced from multiple manufacturing lots, demonstrating their reproducibility. We are working now to complete our analysis of the data for inclusion into our 510(k) package to the FDA, which we expect to submit in the next few weeks.”
Commercialization Activates Proceeding In Parallel
The CEO also went on to explain that the while the development team will go full steam ahead with the review and packaging of data to be presented to FDA, its commercialization teams are going to extend their efforts at reading the ground for the simultaneous launch of “CE Marked APPY1 Test” in Europe and U.S. He indicated that the ground teams have already started collating data on hospitals and diagnostic centers which could be their target customer base.