REDxFLOQ SARS-CoV-2 Antigen as IVD Controls in Canada, the EU, and the U.S.
MISSISSAUGA, March 11, 2021 – Microbix Biosystems Inc. (TSX: MBX, OTCQB: MBXBF, Microbix®), a life sciences innovator and exporter, announces the availability of more of its Quality Assessment Products (QAPs™) as In-Vitro Diagnostic “IVD” Controls – to monitor the workflow accuracy of antigen-based tests for the virus causing COVID-19 disease in Canada, the EU, and the United States.
Antigen-based tests look for intact or fragmented virus within a patient sample, which can be taken and analyzed at the same point-of-care or at a clinical laboratory. Such tests are proving to be a faster and less expensive option for widespread population-based screening for COVID-19 disease, although they are not replacing lab-based nucleic-acid (“NAAT” or “RT-PCR”) testing for definitive diagnosis of individuals.
Microbix created its antigen-test QAPs to support laboratory proficiency-testing and accreditation, test development or staff training, and monitoring of clinical lab workflows. External validation of these QAPs was completed in October, 2020 with a Research-Use-Only “RUO” version of the product becoming available at that time. Microbix has now completed the extensive “technical file” required for regulatory purposes to permit product usage for monitoring the accuracy of lab-based patient-testing workflows. The resulting IVD versions are branded as “REDx™FLOQ® SARS-CoV-2 Ag” positive and negative controls that are room-temperature stable for 12-months and formatted on COPAN® FLOQSwabs®. At present, Microbix’s REDxFLOQ SARS-CoV-2 Ag controls have confirmed compatibility with 27 different COVID-19 antigen tests, thereby providing a complete quality solution for health systems deploying multiple tests.
Microbix’s antigen-test QAPs are already being widely used and recommended for lab proficiency testing and accreditation, onboarding new instruments, and training technicians. Such RUO uses are now joined by availability for supporting laboratory quality management systems. Microbix’s antigen-test QAPs also compliment its IVD COVID-19 PCR-test QAPs (REDx™FLOQ® SARS-CoV-2 & REDx™ Controls SARS-CoV-2) that have been successfully adopted to support proficiency testing, training, and quality management at clinical labs in Australia, the EU, North America, Scandinavia, and the UK. Microbix remains committed to continuing to build its portfolio of innovative, proprietary, and branded QAPs – now at six IVD Controls for COVID-19 testing and six others for sexually-transmitted diseases (four HPV and two Mgen).
As for all Microbix QAPs, its COVID-19 antigen-test versions are optimized to assist quality management systems regardless of what specific tests are in use and additional to whatever on-board controls are used within particular tests. As such they supplement accuracy without risk to patients.
Cameron Groome, President and CEO, stated, “We welcome being able to make these antigen-test QAPs widely-available to monitor workflow accuracy at clinical laboratories. I thank our internal product development, manufacturing, and regulatory teams, and also our collaborators for enabling us to provide healthcare systems with another important tool for helping to manage the COVID-19 pandemic.”
About Microbix Biosystems
Microbix develops proprietary biological and technology solutions for human health and well-being, with about 90 skilled employees and sales growing from a base of over $1 million per month. It makes a wide range of critical biological materials for the global diagnostics industry, notably antigens for immunoassays and its laboratory quality assessment products (QAPs™) that support clinical lab proficiency testing, enable assay development and validation, or help ensure the quality of clinical diagnostic workflows. Microbix antigens enable the antibody tests of over 100 international diagnostics companies, while its QAPs are sold to clinical laboratory accreditation organizations, diagnostics companies, and clinical laboratories. Microbix QAPs are now available in over 30 countries, distributed by 1WA, Alpha-Tec Systems, Inc., Diagnostic International Distribution S.p.A., Labquality Oy, The Medical Supply Company of Ireland, and R-Biopharm AG. Microbix is ISO 9001 and 13485 accredited, U.S. FDA registered, Australian TGA registered, Health Canada establishment licensed, and provides CE marked products.
Microbix also applies its biological expertise and infrastructure to develop other proprietary products and technologies, most notably viral transport medium (DxTM™) to stabilize patient samples for lab-based molecular diagnostic testing and Kinlytic® urokinase, a biologic thrombolytic drug used to treat blood clots. Microbix is traded on the TSX and OTCQB, and headquartered in Mississauga, Ontario, Canada.
This news release includes “forward-looking information,” as such term is defined in applicable securities laws. Forward-looking information includes, without limitation, all discussion regarding Microbix products, the uses or regulation of Microbix products, Microbix’s business and business results, goals or outlook, risks associated with financial results and stability, development projects such as those referenced in its corporate presentation, regulatory compliance and approvals, sales to domestic or foreign jurisdictions, engineering and construction, production (including control over costs, quality, quantity and timeliness of delivery), foreign currency and exchange rates, maintaining adequate working capital and raising further capital on acceptable terms or at all, and other similar statements concerning anticipated future events, conditions or results that are not historical facts. These statements reflect management’s current estimates, beliefs, intentions and expectations; they are not guarantees of future performance. The Company cautions that all forward looking information is inherently uncertain and that actual performance may be affected by a number of material factors, many of which are beyond the Company’s control. Accordingly, actual future events, conditions and results may differ materially from the estimates, beliefs, intentions and expectations expressed or implied in the forward-looking information. All statements are made as of the date of this news release and represent the Company’s judgement as of the date of this new release, and the Company is under no obligation to update or alter any forward-looking information.
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For further information, please contact Microbix at:
|Cameron Groome, CEO
|Jim Currie, CFO
|Deborah Honig, Investor Relations
Adelaide Capital Markets
(647) 203-8793 firstname.lastname@example.org
Copyright © 2021 Microbix Biosystems Inc.
Microbix®, DxTM™, Kinlytic®, ONBOARDx™, PROCEEDx™, QAPs™, and REDx™ are trademarks of Microbix Biosystems Inc.
PROCEEDx™FLOQ® and REDx™FLOQ® are trademarks of Microbix Biosystems Inc. in collaboration with Copan Italia S.p.A.
Copan®, FLOQ®, and FLOQSwab® are trademarks of Copan Italia S.p.A.