In vitro diagnostic company Venaxis has filed for CE mark approval of blood-based appendicitis test, APPY1, in Europe.
The company expects to receive CE Mark by the end of 2012 and anticipates initiating commercialization in first quarter 2013 in territories such as the UK, Italy, France, Germany and Benelux countries.
Venaxis chief commercial officer Don Hurd said, "Our goal in Europe is to be positioned for a successful launch as soon as possible after obtaining CE Mark, and I’m proud to say that we are well on our way to meeting that goal."
The company produced multiple commercial-scale manufacturing lots of APPY1, as part of the technical data submission for CE marking.
Subsequent to the analytical testing of the individual lots, product conformity with CE requirements has been declared.
According to the company, the products lots will support the initial European launch in addition to the planned US pivotal trial of APPY1.
Venaxis president and CEO Steve Lundy said, "We are currently prepared to begin enrolling patients into the pivotal study; however, we believe it is in Venaxis’ best interest, and the best interest of our shareholders, to leverage every available opportunity to interact with the FDA."