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QAPs™ To Support Accuracy Of COVID-19 Antigen-Test Workflows
MISSISSAUGA, CANADA, October 20, 2020 – Microbix Biosystems Inc. (TSX: MBX, OTCQB: MBXBF, Microbix®), a life sciences innovator and exporter, announces its creation, external verification, initial sales, and first shipments of a new class of quality assessment products (QAPs™) to help implement or ensure workflow accuracy of antigen-based tests for the virus causing COVID-19 disease.
Antigen-based tests look for intact or fragmented virus within a patient sample, which can be taken and analyzed at the same point-of-care. Such tests are proving to be a faster and less expensive option for screening for COVID-19 disease, although they will likely not replace lab-based nucleic-acid (“NAAT” or “RT-PCR”) testing for definitive diagnosis. An initial group of antigen-based tests have been authorized for emergency use by authorities such as the United States FDA, which has made six such tests available.
Microbix created its antigen-test QAPs to support laboratory proficiency testing and accreditation, test development or lab training, and support of clinical lab workflows. External validation of these products has been completed with multiple test makers and is one of the catalysts for the current disclosure.
Furthermore, yesterday Microbix shipped over a thousand units of a prototype of these QAPs – purchased by international proficiency-testing and accreditation agencies for widespread clinical lab confirmations of their reliability across the COVID-19 antigen-tests now coming into use. Upon receipt of such widespread validation, Microbix will complete assembly of the detailed technical file necessary to register/license its COVID-19 antigen-test QAPs for clinical lab use. With regulatory work completed, they will become available for lab testing workflow support – as “REDx™FLOQ® SARS-CoV-2 Ag” positive and negative samples that are room-temperature stable and formatted on COPAN® FLOQSwabs®.
Microbix believes these COVID-19 antigen-test QAPs compliment the COVID-19 nucleic-acid test QAPs created this spring (REDx™FLOQ® SARS-CoV-2 & REDx™ Controls SARS-CoV-2) that have since been successfully adopted to support proficiency testing, lab training, and the quality management systems of clinical laboratories in Australia, the European Union, North America, Scandinavia, and the UK. Microbix remains committed to continuing to build its portfolio of innovative, proprietary, and branded QAPs – currently focused within the respiratory and sexually-transmitted categories of infectious disease.
As for all Microbix’s QAPs, the COVID-19 antigen-test variants are designed to provide support for quality management systems regardless of what specific tests are in use and additional to whatever on-board controls are used within particular tests. As such they supplement accuracy without risk to patients.
Cameron Groome, President and CEO, stated, “We look forward to being able to make these new QAPs widely-available to support test development or deployment, lab training and accreditation, and lab testing workflows. I thank our internal product development teams and external collaborators for creating another important tool for helping worldwide health systems manage the COVID-19 pandemic.”
Microbix will discuss its QAPs portfolio, viral transport media project, and broader business outlook during a webinar on Wednesday, October 21 at 11:00 AM Eastern Time (ET). To attend, RSVP via hyperlink to https://us02web.zoom.us/webinar/register/WN_wyzCPXI6QNm_PhbLzmNYPQ. The webinar will be live-streamed to https://www.youtube.com/channel/UC7Jpt_DWjF1qSCzfKlpLMWw (the YouTube channel of Adelaide Capital) and a replay will also be posted.
About Microbix Biosystems
Microbix develops proprietary biological and technology solutions for human health and well-being, with approximately 80 skilled employees and sales 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 Kinlytic® urokinase, a biologic thrombolytic drug used to treat blood clots. Microbix is publicly-traded on the TSX and OTCQB, 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, references to new products or their utility, regulatory paths and authorities, discussion of financial results or the outlook for the business, risks associated with its financial results and stability, its current or future products, development projects such as those that may be referenced herein, 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.
Please visit www.microbix.com or www.sedar.com for recent Microbix filings.
For further information, please contact:
| 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 |