Microbix COVID-19 QAPs Attain EU “CE mark” Registration

Enables Usage of SARS-CoV-2 Controls by Clinical Labs across Europe

MISSISSAUGA, Ontario, June 05, 2020 (GLOBE NEWSWIRE) -- Microbix Biosystems Inc. (TSX: MBX, Microbix), an award-winning life sciences innovator and exporter, is pleased to announce the attainment of European Union “CE mark” (Conformité Européene) registration for its SARS-CoV-2 quality assessment products (QAPs) – CE mark registration enables Microbix’s network of distributors that now covers 18 EU countries to immediately begin providing these products to clinical laboratories across the EU.

Microbix has attained CE marking in compliance with the European In-Vitro Diagnostic Devices Directive (98/79/EC). Complying with Italian requirements for implementation of the Directive, Microbix has also obtained the National Registration with the Italian Ministry of Health.  This permits sale of its SARS-CoV-2 Positive and Negative Controls throughout the countries where Microbix has EU-compliant distribution and quality agreements. At present, that comprises the following EU and Nordic countries, with one outlier in that, unlike the other 17, registration is not yet completed for REDx^TM brand controls in Latvia:

Belgium

Ireland

Norway

Denmark

Italy

Northern Ireland

Estonia

Latvia

Poland

Finland

Lithuania

Spain

France

Luxembourg

Sweden

Germany

Netherlands

United Kingdom

It has been widely reported that recently-deployed tests for the virus causing COVID-19 disease can provide results of questionable accuracy – “false negative,” or “false positive” results.  The four Microbix SARS-CoV-2 QAPs (+ & - swabs or vials) are to increase the reliability of nucleic-acid test (NAT) results.