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Be the first with the news that moves the market- Biotechnology company, Microbix Biosystems (TSX:MBX) has FDA registration for the use of its COVID-19 quality assessment products in US labs
- A number of recently deployed tests meant to detect the SARS-CoV-2 virus have provided results with questionable accuracy
- Microbix’s quality assessment products (QAP’s) can assess and improve the reliability of nucleic-acid COVID-19 tests
- The company will now look to make the tests available to US laboratory chains, purchasing organisations, and procurement agencies
- Microbix Biosystems is down 1.49 per cent, and is currently trading for $0.33 per share
Biotechnology company, Microbix Biosystems (TSX:MBX) has FDA registration for the use of its COVID-19 quality assessment products in US labs.
The ability to quickly, accurately, and reliably detect the SARS-CoV-2 virus has been essential in the fight against COVID-19. Unfortunately, a number of recently deployed tests for the virus have been providing false negatives or false positives. These incidents make it difficult to trust and rely upon the results they give.
Microbix has developed quality assessment products (QAP’s) which can assess and improve the reliability of NAT (Nucleic acid tests) results. The company’s QAP’s work with multiple NAT methods which detect the virus that causes COVID-19.
Microbix is making its QAP’s available for various testing formats. These include REDxFLOQ SARS-CoV-2 for swabs and REDxFLOQ SARS-CoV-2 for liquid aliquots (samples).
The company registered its products with the US Food and Drug Administration (FDA), allowing US clinical laboratories to use them. It also permits the sale of its SARS-CoV-2 Positive and Negative Controls.
Microbix’s CEO, Cameron Groome, commented on the registration which enabled the QAP’s availability.
“We’re pleased to have completed the process of registering our SARS-CoV-2 Controls to permit their sale as controls to clinical labs in the United States.
“Microbix will now engage with American laboratory chains, group purchasing organisation, and procurement agencies to make certain that the US healthcare system can benefit from Microbix’s products that help to ensure test accuracy,” he said.
Microbix Biosystems is down 1.49 per cent, and is trading for $0.33 per share, as of 11:00am EDT.
