MSwab® & PROCEEDx™FLOQ® Supporting Self-Collection for HPV Screening Programs
MISSISSAUGA, Ontario, Oct. 06, 2022 (GLOBE NEWSWIRE) -- Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, announces that, on behalf of Santina Castriciano of Copan Italia S.p.A. and in collaboration with Victorian Cytology Service of the Australian Centre for the Prevention of Cervical Cancer (VCS Pathology), it will present results of novel methods to support diagnostic accuracy and whole-process workflow validation of cervical cancer screening tests on self-collected patient specimens. The poster presentation will be made at the 12th European Meeting on Molecular Diagnostics (“EMMD”) taking place in Noordwijk, Netherlands from October 12 to 14, 2022.
Ample evidence supports use of self-collected vaginal samples to improve participation in cervical cancer screening programs based on molecular (“MDx”) detection of Human Papilloma Virus (“HPV”). However, broad adoption of self-collection has been set-back by a lack of materials and methods to evaluate the whole workflow experienced by a specimen – from collection to final diagnostic result. This critical gap is bridged by the current study using Microbix PROCEEDx™FLOQ® simulated positive HPV samples eluted into Copan MSwab® medium – evaluating whether HPV was effectively eluted from the simulated self-collected swabs and then detected by commercial in vitro diagnostic (“IVD”) PCR-based MDx assays.
The study determined that three positive specimens simulating infection with high-risk HPV types (16, 18 & 45) and a negative sample were detected and individually identified on six IVD MDx assays: the Abbott Alinity m HPV & Abbott Realtime HPV, Qiagen NeumoDx HPV, Roche cobas 4800 HPV & Roche cobas 6800 HPV, and Seegene Anyplex II HPV28. Accuracy was 100% across all sample types and assays. The poster will be available on Microbix’s website (https://microbix.com) and from EMMD after its presentation.
HPV represents a family of over 100 virus sub-types, of which 14 are deemed “high-risk” as they are proven to directly cause cancers, including but not limited to cervical cancer. Most sexually-active adults become infected with one or more types of HPV and such infections can be persistent. MDx tests permit early detection and guide timely preventative healthcare by identifying those at-risk years before the development of cancers. However, MDx-based screening programs require rigorous workflow design and ongoing validation to ensure their accuracy. Many healthcare systems now plan to resume the roll-out of MDx-based HPV screening programs that were delayed as a result of the COVID-19 pandemic, important diagnostic healthcare advancements that Microbix is pleased to support with its products and services.
Empowering women to collect vaginal samples in private, safe, and convenient locations is expected to promote patient access to healthcare and accelerate the widespread adoption of MDx-based HPV and cervical cancer screening programs. Microbix is proud to be a strategic partner of Copan and help to accelerate the evolution to self-collection by offering HPV-oriented “PROCEED™FLOQ®” (RUO) and prospective “REDx™FLOQ®” (IVD) quality assessment products (QAPs™) worldwide. Purchase enquiries for Microbix’s QAPs can be e-mailed to firstname.lastname@example.org.
About Microbix Biosystems
Microbix develops proprietary biological products and services for human health and well-being, 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™ IVD or RUO test-controls) 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 Copan, HPV, EMMD, or VCS, 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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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®, FLOQSwab®, and MSwab® are trademarks of Copan Italia S.p.A.
Other parties’ corporate or product names referenced herein may be the trademarks of their respective companies.