Initial Capacity of 50,000 Vials/Week under Health Canada Regulation
MISSISSAUGA, January 28, 2021 – Microbix Biosystems Inc. (TSX: MBX, OTCQB: MBXBF, Microbix®), a life sciences innovator and exporter, is pleased to announce the commercial availability of its viral transport medium (VTM) to support Canadian RT-PCR (molecular) testing for the virus causing COVID-19 disease.
At the request of the Government of Ontario, Microbix has created a secure and locally-based supply of high-quality VTM, any shortage of which limits capacity for COVID-19 testing. Microbix has begun its VTM production at 50,000 vials per week using semi-automated methods and, again at Ontario’s request, is targeting more-automated production of over 400,000 vials per week by the end of its fiscal 2021.
In October 2020, the Honorable Vic Fedeli, Minister of MEDJCT, Minister responsible for OTF, and Member of Provincial Parliament for Nipissing, approved an Ontario Together Fund grant of $1.45 million to cover 50% of the cost to scale-up production of two emerging Microbix product lines – its VTM (now branded as DxTM™), and its growing portfolio of test quality assessment products (QAPs™) which are helping manage the pandemic across Canada, and in Australia, the EU, Scandinavia, the UK, and the US.
DxTM is now available for use throughout Canada, manufactured and distributed under Microbix’s Health Canada Medical Devices Establishment License (MDEL) and its ISO quality management systems. The suitability of DxTM has been evaluated across multiple test platforms by Public Health Ontario – based on trials of hundreds of samples provided by Microbix. DxTM is produced entirely at Microbix’s facilities in Mississauga, Ontario and its critical ingredients and materials are sourced from Canadian suppliers.
Microbix is currently in discussions with Plexxus, a leading supply-chain organization that supports hospitals in Ontario, to procure DxTM for testing programs within the province. Any supply of DxTM not procured by Plexxus or other representatives of the Government of Ontario will be made available on a first-come-first-served basis – including to other provinces and private testing organizations.
DxTM is provided in a vial that is sized to accommodate nasopharyngeal swab segments of up to 10 cm in length. Internal and external studies indicate excellent viral RNA recovery and strong product shelf-life. Further DxTM information is available at www.microbix.com and purchase enquiries can be made by e-mail to email@example.com. COVID-19 testing organizations are also encouraged to use Microbix’s PROCEEDx™ “RUO” samples or REDx™ “IVD” controls to support molecular or antigen tests.
Cameron Groome, CEO & President of Microbix, remarked, “We’re pleased to fulfill our commitment to provide this critical testing medium and do it so soon after receiving grant funding from Ontario. Our team has done superlative work in creating this product, validating and scaling processes for its manufacture, proving its utility and stability, and completing the necessary technical files. We look forward to seeing DxTM in widespread use within Ontario and, as appropriate, elsewhere in Canada.”
About Microbix Biosystems
Microbix develops proprietary biological and technology solutions for human health and well-being, with about 80 skilled employees and sales growing from a base of approximately $1 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 20 countries, distributed by Alpha-Tec Systems, Inc., Diagnostic International Distribution S.p.A., Labquality Oy, The Medical Supply Company of Ireland, and R-Biopharm AG. 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 OTCQB, 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, all discussion regarding DxTM or other Microbix products, 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 domestic or 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
Copyright © 2021 Microbix Biosystems Inc.
Microbix®, DxTM™, Kinlytic®, PROCEEDx™, QAPs™, and REDx™ 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.