Venaxis, Inc. (Nasdaq: APPY), an in vitro diagnostic company, today announced it has filed for CE Mark approval in Europe for APPY1, the Company's blood-based appendicitis test. Based upon the standard protocol for submission of its technical file for APPY1 through the Company's authorized representative, Venaxis expects to obtain CE Mark under the European Economic Area by the end of the year. Initial commercialization in Europe is planned to commence in the first quarter 2013 in key territories, including the UK, Italy, France, Germany and Benelux countries.
As part of the technical data submission for CE marking, Venaxis successfully produced multiple commercial-scale manufacturing lots of APPY1. Based upon successful analytical testing of these individual lots, conformity of the product with CE requirements has been declared. These product lots will support the initial European launch, as well as the planned U.S. pivotal trial.
Don Hurd , Chief Commercial Officer of Venaxis, stated, "This is a landmark accomplishment for Venaxis. I congratulate our team for their successful execution on the multitude of stringent provisions and directives required for CE marking, which include capabilities in product development, lot manufacturing, packaging and labeling design. Meeting these high standards is not a trivial endeavor and it would not have been possible without significant dedication by our team. With the completion of this important regulatory step, we are focusing on market development. 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. We continue to advance our discussions with potential distributors as well as glean meaningful market insight from the key opinion leader hospital sites we are engaging in our target territories. We look forward to providing further updates on our progress as we prepare to launch APPY1 in Europe."
The Company has begun the process of developing relationships with five to eight select hospitals in each of the target European territories. The goal is to establish Venaxis and APPY1 with key professionals at these key opinion leader hospital sites in order to develop a potential customer base. These relationships will help Venaxis validate its current assumptions about the European market, as well as allow the Company to better understand the optimal approach to full-scale launch. These market development efforts remain a top priority for Venaxis and will continue into 2013 as the launch progresses.