QAPs Supporting Molecular Diagnostic Tests for Dominant COVID-variant
MISSISSAUGA, CANADA, April 29, 2022 – Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, announces it will present performance results of its Quality Assessment Products (“QAPs™”) supporting molecular-diagnostic tests for the Omicron variant of the SARS-CoV-2 virus (“Omicron”) at the 2022 Clinical Virology Symposium of the American Society for Microbiology (“CVS”) taking place in West Palm Beach, Florida from May 1-4, 2022.
At CVS, Microbix will be exhibiting alongside leading diagnostics firms that provide tests for detection of COVID and other infectious diseases. Microbix will also review performance of its QAPs to support quality management of testing for infection with Omicron (the B.1.1.529 variant of SARS-CoV-2).
Its poster presentation is titled “Use of SARS-CoV-2 Omicron External Controls for Verifying the Performance of Primary and Reflex SARS-CoV-2 Molecular Detection Methodologies.” The poster details the performance of Microbix’s Copan® FLOQSwab® formatted, room-temperature stable, and whole-genome Omicron-focused QAPs in challenging the accuracy of molecular (e.g., PCR-based) assays testing for mutations specific for this dominant variant and the generic tests designed to target only the wild type. The poster will be made available on Microbix’s website (https://microbix.com) and from CVS following its presentation.
With over 50 reported mutations in its viral genome, Omicron can lead to reduced assay sensitivity or the outright inability of assays to detect it. Use of Microbix’s REDxFLOQ or PROCEEDxFLOQ QAPs offer whole-genome controls that contain all Omicron mutations and provide lot-to-lot consistency in order to optimally support clinical laboratories and test-makers in monitoring their assay performance.
Microbix now has QAPs to support tests for six (6) variants of the virus that causes COVID available for sale in Canada, Europe, the United States, and other commercially-important jurisdictions under its “REDx™” or “PROCEEDx™” brand names. Its QAPs support tests for the “Wuhan” strain, as well as those variants that have since become most prevalent, including the Alpha (B.1.1.7 or UK), Beta (B.1.351 or South African), Delta (B.1.617 or Indian), Gamma (P.1 or Brazilian), and Omicron (B.1.1.529 or Botswana).
Microbix is proud to be a strategic partner of Copan and offer a broad portfolio of infectious-disease oriented “PROCEED™FLOQ®” (RUO) and “REDx™FLOQ®” (IVD) QAPs to support testing programs worldwide. Further information about Microbix’s QAPs is available at https://microbix.com and purchase enquiries for Microbix’s QAPs™ can be e-mailed to firstname.lastname@example.org.
About Microbix Biosystems
Microbix creates proprietary biological products for human health, with over 100 skilled employees and sales approaching C$ 2.0 million per month. It makes a wide range of critical ingredients and devices 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. Its antigens drive the antibody tests of over 100 diagnostics makers, while 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 CVS, the poster or its relevance, the products of Microbix or its collaborators, 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 or 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
Copyright © 2022 Microbix Biosystems Inc.
Microbix®, DxTM™, Kinlytic®, PROCEEDx™, QAPs™, REDx™ and REDx™ Controls 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.