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UK renews approval for Zila's oral cancer test "indefinitely"

This article was originally published in Clinica

Executive Summary

The UK's Medicine's and Healthcare products Regulatory Agency (MHRA) has renewed the marketing authorisation for Zila's oral cancer diagnostic kit, OraTest. Under the EU's mutual recognition procedure (where approval in one member state is recognised by others), the Phoenix, Arizona firm expects to receive renewal licences in six other member states: Finland, Greece, Luxembourg, the Netherlands and Portugal. OraTest is indicated as an adjunct to visual examination in patients at high risk for oral cancer, or to monitor patients who have previously had the disease. It contains Zila's tolonium chloride rinse product, which is combined with the firm's ViziLite chemiluminescent light source to identify suspicious lesions.

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