Whole-genome QMS Support Tool on COPAN® FLOQSwabs®
MISSISSAUGA, CANADA, March 30, 2020 – Microbix Biosystems Inc. (TSX: MBX, Microbix®) announces the creation, verification, and imminent commercial availability of a quality assessment product (QAP™) to help ensure the accuracy of COVID-19 disease testing.
By creating this unique product, Microbix is contributing to the development of new methods and improved methods for SARS-CoV-2 virus (COVID-19) detection and is helping to improve the accuracy of existing protocols by providing reliable, whole-genome validation/verification and training samples.
Microbix currently has capacity to make five-thousand (5,000) units per week of room-temperature stable COVID-19 QAPs exclusively on COPAN® FLOQSwabs®, with a liquid-format COVID-19 QAP also available. Such QAPs can be shipped immediately to support the verification of new testing methods, the validation of newly-placed test instruments, the training of technicians, and the attainment of laboratory proficiency accreditations. Further regulatory authorizations will be sought on an emergency-use basis, and when granted, will permit the release of IVD-labeled versions of Microbix’s COVID-19 products for ongoing quality management system (QMS) support of clinical laboratories. By way of example, at usage of one per hundred tests, such QAPs would help ensure the accuracy of 500,000 COVID-19 tests per week.
Cameron Groome, President and CEO, stated, “We’re pleased to be able to immediately offer assistance to health professionals in the global fight against this recently-emerged pandemic. Microbix is grateful to our staff and external collaborators for their work in creating and validating this essential product so quickly. We also want to provide a message of heartfelt thanks and support to our friends at COPAN Italia, who are enduring so much while working 24/7 to provide their vital sample collection swabs to hospitals and labs around the world.”
This new and innovative Microbix product has been shown to work with nucleic-acid based test (NAT) methods used to detect the SARS-CoV-2 virus that causes COVID-19 disease, specifically that published by the U.S. Centers for Disease Control (run at MBX) and of Seegene, Inc. (Allplex™ 2019-nCoV assay, run externally at KoronaDx). Microbix will now file for emergency-use authorizations from Health Canada, the U.S. Food and Drug Administration (FDA), and other regulatory authorities, while concurrently conducting further external verifications across more of the test platforms now in use. Once authorizations are received, the products will be made available as REDxFLOQ™ SARS-CoV-2 for swabs and as REDx™ Control SARS-CoV-2 for liquid aliquots.
As for all Microbix QAPs, this COVID-19 product is a whole-genome workflow support tool that includes 100% of the genetic sequences of the virus and emulates real patient samples while being consistent, non-infectious, and stable. As such, it contains all possible NAT viral targets – ensuring compatibility across all current and future NATs. This broad compatibility and guaranteed utility is particularly relevant for External Quality Assurance Programs that assess and ensure the performance of testing labs.
Microbix supplies a broad range of white-labeled QAPs, including other viral respiratory pathogens, to support the proficiency testing (PT) programs of laboratory accreditation organizations in North America and Western Europe. Under its PROCEEDx™ brand, Microbix provides RUO (research-use-only) QAPs to support the test validation/verification and operator training objectives of test developers and clinical labs. Full QMS support of clinical laboratory patient sample testing is provided by Microbix’s FDA-registered and CE mark certified REDx® Controls brand QAPs.
About Microbix Biosystems
Microbix develops proprietary biological and technology solutions for human health and well-being, with approximately 80 skilled employees and sales now usually exceeding $1 million per month on average. 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 quality control of clinical diagnostic tests. Microbix antigens and QAPs are sold to many customers worldwide, at present primarily to multinational diagnostics companies and laboratory accreditation organizations.
Microbix also applies its biological expertise and infrastructure to develop other proprietary products and technologies, most notably Kinlytic® urokinase, a biologic thrombolytic drug used to treat blood clots.
Microbix is a publicly-traded company, listed on the Toronto Stock Exchange 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, discussion of the COVID-19 QAP, the utility or consequences of use of the COVID-19 QAP, references to external collaborators and regulatory processes, 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 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.
Please visit www.microbix.com or www.sedar.com for recent Microbix news and filings.
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