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SARS-CoV-2 Controls for Canadian Labs in Swab and Vial Formats
MISSISSAUGA, CANADA, May 6, 2020 – Microbix Biosystems Inc. (TSX: MBX, Microbix®), an award-winning life sciences innovator and exporter, announces that it has begun providing its REDx™FLOQ® SARS-CoV-2 swab-format and REDx™ SARS-CoV-2 vial format quality assessment products (QAPs™) as controls to clinical laboratories in Canada.
A first commercial run of 4,000 units was split between the REDx™FLOQ® SARS-CoV-2 swab-format and REDx™ SARS CoV-2 vial-format, with positives and negatives of each format produced. QAPs from this initial run have now been provided to public health and privately-operated clinical laboratories in Canada, and scheduled for shipment to laboratory proficiency accreditation agencies based in Canada and internationally. At a rate of usage of one positive and one negative control per 100 patient tests in clinical labs, 4,000 QAPs could help support the accuracy of 200,000 tests.
Although Microbix does not currently foresee constraints on supply of unloaded swabs or unfilled vials for this critical public health usage, ongoing production of its QAPS is subject to such supplies. Given such supplies and supporting demand, Microbix has capacity to make 5,000 units/week of room-temperature stable REDx™FLOQ® SARS-CoV-2 swab QAPs, and 10,000 units/week of REDx™ SARS-CoV-2 liquid vial QAPs. Such QAPs can be used to support the verification of new testing methods, the validation of newly-placed test instruments, training of technicians, attainment of lab proficiency accreditations, and by clinical labs for systematic quality control. At usage of one positive and one negative per hundred tests, 15,000 units of QAPs can help ensure the accuracy of 750,000 COVID-19 tests each week.
Cameron Groome, President and CEO, stated, “We’re pleased to be able to make Microbix’s QAPs available to support the integrity of COVID-19 testing programs in Canada and for Canadian and international lab proficiency testing and accreditation. We appreciate the prompt and effective actions of Health Canada, and also thank our first-users for rapidly communicating their initial requirements. Everyone at Microbix considers it a duty and a privilege to employ our expertise to help ensure the accuracy of testing programs and thereby improve public health efforts to control this pandemic.”
These Microbix QAPs have been shown to work with multiple nucleic-acid based test (NAT) methods used to detect the SARS-CoV-2 virus that causes COVID-19 disease, specifically tests targeting a variety of nucleic-acid targets across the genome of the virus. As for all Microbix QAPs, these SARS CoV-2 (COVID-19) QAPs are whole-genome workflow support tools that include 100% of the genetic sequences of the virus and emulate real patient samples while being consistent, non-infectious, and stable. As such, the SARS-CoV-2 (COVID-19) QAPs contain all known potential NAT viral targets – ensuring compatibility across current and future NATs. This broad compatibility and guaranteed utility is particularly relevant in the context of testing during a pandemic, when multiple test protocols and instrument systems are being newly-called into use.
Microbix supplies a broad range of white-labeled QAPs, including other viral respiratory pathogens, to support proficiency testing (PT) programs of lab accreditation organizations in North America, Western Europe, and Scandinavia. Under its PROCEEDx™ brand, Microbix provides RUO (research-use-only) QAPs to support the test validation/verification and operator training objectives of test developers and clinical labs. Full QMS support of clinical laboratory patient sample testing is provided by Microbix’s REDx®FLOQ or REDx™ Controls brand QAPs.
About Microbix Biosystems
Microbix develops proprietary biological and technology solutions for human health and well-being, with approximately 80 skilled employees and sales now usually exceeding $1 million per month on average. 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 quality control of clinical diagnostic tests. Microbix antigens and QAPs are sold to many customers worldwide, at present primarily to multinational diagnostics companies and laboratory accreditation organizations. Microbix is ISO 9001 and 13485 accredited, FDA and 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 Kinlytic® urokinase, a biologic thrombolytic drug used to treat blood clots.
Microbix is a publicly-traded company, listed on the Toronto Stock Exchange and headquartered in Mississauga, Ontario, Canada.
Forward-Looking Information
This news release includes “forward-looking information,” as such term is defined in applicable securities laws. Forward-looking information includes, without limitation, discussion of the COVID-19 QAPs, the utility or consequences of use of the COVID-19 QAPs, references to external collaborators and regulators or regulatory processes, 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
(905) 361-8910 |
Jim Currie, CFO
(905) 361-8910 |
Deborah Honig, Investor Relations
Adelaide Capital Markets (647) 203-8793 ir@microbix.com |