Mr. Cameron Groome reports
MICROBIX COVID-19 QAPS ATTAIN EU "CE MARK" REGISTRATION
Microbix Biosystems Inc. has attained European Union CE mark registration for its SARS-CoV-2 quality assessment products (QAPs). CE mark registration enables Microbix's network of distributors, which now covers 18 European Union countries, to immediately begin providing these products to clinical laboratories across the European Union.
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 national registration with the Italian Ministry of Health. This permits the sale of its SARS-CoV-2 positive and negative controls throughout the countries where Microbix has European Union-compliant distribution and quality agreements. At present, that comprises the following European Union and Nordic countries, with one outlier in that, unlike the other 17, registration has not yet been completed for REDx brand controls in Latvia:
- Northern Ireland;
- United Kingdom.
It has been widely reported that recently deployed tests for the virus causing the COVID-19 disease can provide results of questionable accuracy -- false-negative or false-positive results. The four Microbix SARS-CoV-2 QAPs (positive and negative swabs or vials) are to increase the reliability of nucleic acid test (NAT) results.
The Microbix COVID-19 QAPs have been shown to work with multiple NAT methods used to detect the virus causing the COVID-19 disease, specifically tests targeting a variety of nucleic acid targets across the genome of the virus. These Microbix products are being made available as REDx FLOQ SARS-CoV-2 for swabs and as REDx SARS-CoV-2 for liquid aliquots (vials).
Cameron Groome, president and chief executive officer, stated: "We're pleased to have completed the process of registering our SARS-CoV-2 controls to permit their sale as controls to clinical labs across the EU. Microbix's distributors will now engage with European governments, health authorities, hospitals and laboratory chains to make certain that EU health care systems can benefit from these Microbix products."
About Microbix Biosystems Inc.
Microbix Biosystems develops proprietary biological and technology solutions for human health and well-being, with approximately 80 skilled employees and sales exceeding $1-million per month on average.
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