Usage of QAPs to Validate Whole Workflow Quality Control of Testing
MISSISSAUGA, CANADA, June 3, 2022 – Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, announces it is presenting about the utility of its Quality Assessment Products (“QAPs™”) to monitor the end-to-end diagnostic process, including the impact of “preanalytical” sample-handling variables on test accuracy, at the 2022 “Preanalytical Phase Conference” of the American Association of Clinical Chemistry (“AACC”) taking place in Alexandria, Virginia from June 3-4, 2022.
Microbix is attending this AACC conference to present about these important aspects of infectious disease testing, alongside leaders in the global medical diagnostics industry. Microbix will also be conducting business development activities in relation to its expanding portfolio of QAPs, which includes Health Canada, U.S. FDA, EU “CE mark,” or TGA (Australia) in-vitro-diagnostic (“IVD”) regulated SKUs and research-use-only (“RUO”) designated SKUs across both liquid-vial and Copan FLOQSwab® formats.
Its poster presentation is titled “Simulated Swab Specimens for Whole Workflow Quality Control of SARS-CoV-2 Molecular Diagnostic Testing.” The poster details methods of using Microbix’s REDx™FLOQ® SARS-CoV-2 Swab Positive Control QAPs to assess the influence on patient-samples of hold-period durations of up to five (5) days, high temperatures of 35-40 °C, or a freeze-thaw cycle, relative to more optimal conditions. The study examined the effects of such conditions on the detectability of Microbix’s positive QAPs at full-strength and in 1:100 diluted form relative to strong-positive and weak-positive clinical specimens, using two different viral transport mediums (Microbix’s DxTM™ branded viral transport medium and another commercially-available brand) and two different Health Canada approved assays.
The results establish that the effects of sample storage and handling conditions can be accurately modeled using QAPs as proxies for clinical patient-samples. These Microbix products and methods can be used to validate processes for new-generation testing practices, such as at-home sample-collection, for a wide range of disease screening and diagnostic purposes, including COVID-19 and high-risk HPV infection, among others. The study was conducted in collaboration with FH Health Laboratory of Toronto, Ontario, whose support in sourcing clinical specimens, testing, and tabulation is gratefully acknowledged.
Further information about Microbix’s QAPs and its services offerings is available at https://microbix.com and purchase enquiries for QAPs™ can be e-mailed to email@example.com.
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 AACC, 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 firstname.lastname@example.org
Torrey Hills Capital
Copyright © 2022 Microbix Biosystems Inc.
Microbix®, DxTM™, Kinlytic®, QAPs™, REDx™ and REDx™ Controls are trademarks of Microbix Biosystems Inc.
REDx™FLOQ® is a trademark of Microbix Biosystems Inc. in collaboration with Copan Italia S.p.A.
Copan®, FLOQ®, and FLOQSwab® are trademarks of Copan Italia S.p.A.