Company expects to complete the study within six to eight months and file for FDA clearance of APPY1 in the fourth quarter of 2013.
Venaxis president and CEO Steve Lundy said the company expects that 2013 will be a transformative year for it.
"The pivotal clinical study is being conducted at 28 leading hospital sites, each of which are enthusiastic to assist us in completing the study as expeditiously as possible," Lundy added.
"We believe our overall success will be driven by continued execution on clinical and regulatory milestones, and we are pleased to commence patient enrollment in our pivotal U.S. study just days after announcing that APPY1 is now a CE Marked product in Europe. "
Venaxis anticipates launching the product in initial EU territories in addition to working with a network of hospitals to promote APPY1 while the study is being conducted.