APPY post from Natty Greene The test is also being evaluated in a pivotal clinical study in the United States, which is expected to conclude in Q4 2013.
The breakthrough diagnostic test has already been granted marketing approval (CE Mark) in Europe where a launch in multiple countries (U.K., Germany, Italy, France, Turkey, Netherlands) is currently underway. In the U.S., Venaxis is currently conducting a 2,000 patient, pivotal Phase 3 study with results expected in Q4 2013.
CEO interview .... We are actively enrolling patients into the pivotal study, which we expect to support regulatory submission for potential FDA clearance of the APPY1 Test System. The first hospital sites began enrolling patients earlier this year and enrollment has continued to ramp nicely as we continue to bring more of our participating sites on line. The study will enroll 2,000 evaluable patients in total and we expect to complete enrollment and report top-line data by the end of the year. We plan to submit our 510(k) package to the FDA as soon as possible
