Helping Ensure Workflow Accuracy of PCR Tests for COVID “Variants of Concern”
MISSISSAUGA, CANADA, November 17, 2021 – Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator and exporter, announces the expansion of its portfolio of Quality Assessment Products (“QAPs™”) to include controls that support PCR tests for each of the four major variants of concern (“VOCs”) of the SARS-CoV-2 virus that is the cause of the COVID-19 pandemic.
Specifically, Microbix has developed, and is now commercializing, In-Vitro Diagnostic (“IVD”) quality controls to support workflow accuracy of clinical laboratory PCR tests for the Brazilian (P.1), Delta (B.1.617), South African (B.1.351), and UK (B.1.1.7) VOCs. These four VOCs are in addition to QAPs for the original Wuhan strain of the virus and are made using COPAN® FLOQSwabs® – the optimal format for accuracy and point-of-care use, plus room-temperature stability for 12 months. As for all Microbix’s QAPs, these VOC products contain all possible PCR targets and are validated on multiple test platforms.
These new QAPs are branded as a REDx™FLOQ® SARS-CoV-2 P.1, B.1.617, B.1.351 or B.1.1.7 Swab Positive Control respectively and are available to support clinical laboratory quality management system (“QMS”) covering central lab and point-of care workflows in both the U.S. and Canada. Research-Use-Only (“RUO”) PROCEEDx®FLOQ® versions are now available for other markets, with REDx IVD versions to follow.
Microbix’s QAPs portfolio now consists of 70 proprietary SKUs in the categories of respiratory, sexually-transmitted, and gastrointestinal infectious diseases. Of that portfolio, 15 QAPs are available as REDx™ Controls for IVD use by clinical labs. Such Microbix REDx QAPs help manage the accuracy of workflows to avoid the systemic errors that result in false-negative or false-positive test results. Such errors occur and are consequential, as vividly demonstrated by the recent case of an estimated 43,000 false-negative COVID test results at a clinical lab doing COVID PCR testing on behalf of the UK’s National Health Service.
In addition to QAPs to support PCR testing for each of the most important COVID-19 strains, Microbix also has IVD QAPs to support COVID-19 antigen tests (REDxFLOQ SARS-CoV-2 Ag). Microbix’s QAPs for PCR-test and Antigen-test support are also available as ONBOARDx™ kits that include both positive and negative controls for convenient qualification of new instruments for clinical use and for the training of laboratory staff. This portfolio of COVID-oriented QAPs is in widespread use and can be paired with Microbix’s DxTM™ viral transport medium to enable collection and stabilization of patient test-sample specimens.
Cameron Groome, CEO and President of Microbix, commented “Microbix has been providing critical test ingredients to the diagnostics industry for over three decades. So it is our duty and privilege to apply that expertise to helping health authorities, clinical labs, test-makers, and lab accreditation agencies implement and conduct the widespread screening and diagnostic testing needed to mitigate the pandemic. I thank our staff, collaborators, suppliers, customers, and regulators for helping us to create these important new products and make them available to labs across Canada and the United States.”
About Microbix Biosystems
Microbix develops proprietary biological technology solutions for human health and well-being, with about 100 skilled employees and sales nearing C$ 2.0 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 (Oneworld Accuracy Inc.), Alpha-Tec Systems, Inc., Diagnostic International Distribution SpA., Labquality Oy, The Medical Supply Company of Ireland, R-Biopharm AG, SDT Molecular Pte Ltd, Seegene Canada Inc., and Thomas Scientific LLC. 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 OTCQX, 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 QAPs and their relevance or timing, 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.
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For further information, please contact Microbix at:
|Cameron Groome, CEO
Adelaide Capital Markets
(647) 203-8793 email@example.com
Torrey Hills Capital
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