- Microbix Biosystems (MBX) has received Australian Therapeutic Goods Administration (TGA) approval for its COVID-19 quality assessment products
- The approval, which was made via the company’s distributor R-Biopharm, allows the products to be offered to Australian clinical laboratories
- Microbix’s quality assessment products are thought to be the only third-party controls to be registered with the TGA to support these clinical laboratories
- As of September 9, Australia had conducted more than 6.7 million tests for COVID-19 disease and recorded over 26,000 cases
- Microbix Biosystems (MBX) is currently steady at 26 cents per share
Microbix Biosystems (MBX) has received Australian Therapeutic Goods Administration (TGA) approval for its COVID-19 quality assessment products.
The registration applies to the company’s REDx Controls and REDx FLOQ products, which are designed to improve accuracy in the testing for COVID-19.
Successful registration with the health authority was made through Microbix’s partner, R-Biopharm, with which it signed a deal to distribute its products throughout Australia in May this year.
The registration declares the products’ compliance with the relevant national regulations, and allows the products to be sold to clinical laboratories nation-wide.
It’s thought that Microbix’s quality assessment products (QAPs) are the only third-party nucleic-acid workflow controls to be registered with the TGA to support these laboratories.
The company’s QAPs have already demonstrated their effectiveness in detecting the SARS-CoV-2 virus, which causes COVID-19, as well as high-risk types of HPV that are directly implicated as the cause of multiple human cancers.
Cameron Groome, President and CEO of Microbix Biosystems, said he is pleased with the successful registration.
“We intend for our QAPs to support the accuracy of testing for COVID-19 disease and high-risk HPV infections throughout Australia and its territories, as they’re now doing in numerous other countries across the European Union, North America, Scandinavia, and the UK,” he added.
As of September 9, Australia has conducted more than 6.7 million tests for COVID-19 and recorded just over 26,000 cases.
Microbix Biosystems (MBX) is currently steady at $0.26 per share, as of 12:04pm EDT.