Zila wins marketing authorization for oral cancer diagnostic kit

Under the EU’s mutual recognition process, the company expects to receive renewal licenses for member states including Finland, Greece, Luxembourg, The Netherlands, Belgium, the UK and Portugal, over the next 30 to 60 days. The company is seeking marketing partners in the seven EU countries.

Pursuing regulatory approval in additional EU countries is under evaluation. Since the initial approvals of OraTest in the EU, Zila has compiled additional evidence-based data in support of approval.

OraTest is indicated as an adjunct to visual examination in patients considered at high risk for having high-grade premalignancies or malignant lesions. The product can also be used to monitor patients with previously treated oral squamous cell carcinoma for recurrent disease. The kit contains Zila’s patented, pharmaceutical grade tolonium chloride rinse product.

David Bethune, Zila’s chairman and CEO. “The OraTest diagnostic kit and ViziLite Plus, our proprietary oral cancer screening technology, are complementary products with distinct indications, which will allow us to market to a more diverse group of healthcare professionals within the EU.”