MedMira receives CE Mark for MiraCare HIV test

By Lisa Kerner

Erie, Pa., Jan. 17 - MedMira Inc. said its MiraCare Rapid HIV Antibody Test has received CE Mark and is now approved for sale throughout the European Union.

This clears the way for MedMira to market and sell MiraCare in the 25 E.U. member countries, according to a company news release.

"We are very pleased to receive the CE Mark, the final step in the pre-market process," Stephen Sham, chairman and chief executive officer of MedMira, said in the release. "MedMira is now fully enabled to move forward with fulfillment of our first order for 400,000 MiraCare tests destined for Spain and capitalize on further sales opportunities in other regions of the EU."

Obtaining the CE Mark for MiraCare lays a solid foundation for E.U. regulatory approval of MedMira's entire suite of rapid diagnostics, including its combination HIV/Hepatitis C rapid test, officials said.

Approved for use with whole blood, as well as serum and plasma specimens, MiraCare is designed for near-patient settings such as pharmacies and hospitals, as well as laboratories, in Europe. Sold as a complete test kit with all components required to perform the test, it provides test results instantly.

Based in Halifax, N.S., MedMira manufactures and markets in vitro flow-through rapid diagnostic tests.

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