The approval would enable its network of distributors to start providing QA products to clinical laboratories across the 18 EU countries
Microbix Biosystems has secured the European Union (EU) CE mark registration for its SARS-CoV-2 quality assessment products (QAPs).
The life sciences company said that CE mark approval would enable its network of distributors to start providing QA products to clinical laboratories across the 18 EU countries.
In addition, the company has received the CE marking in compliance with the European In-Vitro Diagnostic Devices Directive, and has also obtained the National Registration with the Italian Ministry of Health, in line with the Italian requirements for implementation of the Directive.
Microbix Biosystems president and CEO Cameron Groome said: “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 healthcare systems can benefit from these Microbix products.”
QAPs developed by Microbix will increase the reliability of nucleic-acid test (NAT) results
The regulatory approval allows the company to commercialise its SARS-CoV-2 Positive and Negative Controls across the countries where it has EU-compliant distribution and quality agreements.
Microbix said that its 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, including positive and negative swabs or vials, are said to increase the reliability of nucleic-acid test (NAT) results.
In addition, the Microbix Covid-19 QAPs have been designed to work with multiple NAT methods for detecting the SARS-CoV-2 virus and specifically tests targets different nucleic-acid targets across the virus genome.
Microbix said that its products are being commercialised as REDxFLOQ SARS-CoV-2 for swabs, and as REDx SARS-CoV-2 for liquid aliquots.