Microbix & Oneworld Create COVID-19 Test Quality Program

Laboratory External Quality Assessment, Proficiency Testing, & Accreditation


MISSISSAUGA, Ontario and VANCOUVER, British Columbia, April 09, 2020 (GLOBE NEWSWIRE) -- Microbix Biosystems Inc. (TSX: MBX, Microbix®) and Oneworld Accuracy (1WA) announce a strategic collaboration to provide a global external quality assessment (EQA) program to support clinically-effective COVID-19 testing. Based in Canada, this program will be made available to all governments to underpin their public health responsibility to ensure accurate and reliable COVID-19 testing. In every country and more than ever, political leadership, medical professionals, and the public need to have confidence in patient test results. 

This EQA program will first be launched in Canada then, as production scales, be rolled-out worldwide – likely over the next few months. Details are available online at www.microbix.com and www.1wa.org.

Microbix will provide all EQA samples for this global program, including its SARS-CoV-2 quality assessment products (QAPs™), branded as REDx™FLOQ® SARS-CoV-2 on COPAN® FLOQSwabs®, and as REDx™ Controls in liquid format. The SARS-CoV-2 QAPs provide whole-genome workflow support that includes 100% of viral genetic sequences and emulate real patient samples while being consistent, non-infectious, and stable. As such, they contain all possible nucleic-acid test (NAT) viral targets, ensuring compatibility across current and future NATs. The SARS-CoV-2 QAPs are representative of Microbix’s established catalogue of QAPs of viral and bacterial respiratory pathogens, which have years of successful global usage and are demonstrated to work across more than 20 different widely-used test formats.

Cameron Groome, CEO of Microbix commented, “This collaboration combines Microbix’s demonstrated expertise in making innovative and cross-platform EQA samples with 1WA’s leading EQA informatics and logistics expertise.  1WA’s collaborative model provides this new EQA program access to more than sixty participating governments. Alongside 1WA, we’re pleased to be able to enable a global EQA program and make a significant public health contribution to fighting the COVID-19 pandemic.”

1WA will manage all informatics and logistics for this global EQA program for the current network of governments that have adopted collaborative EQA, and for further governments that need EQA to underpin the quality of their COVID-19 testing efforts.

Daniel Taylor, CEO of 1WA also commented, “We have already begun to assemble an international scientific advisory board to optimize the design of this vital program and analyze the resulting data sets.  We believe the program and its scientific advisory board will uniquely support public health responses to the COVID-19 pandemic. In particular, the program can be readily implemented in low- and middle-income countries where COVID-19 may have a disproportionate impact. Participating governments can be made fully operational as national EQA providers with a few days by way of online training.”

About Microbix (MBX)
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 certified to ISO 9001:2015, ISO 13485:2016, and operates under U.S. FDA Establishment Registration #3007652384. 

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 dissolve blood clots. Microbix is a publicly-traded company, listed on the Toronto Stock Exchange and headquartered in Mississauga, Ontario, Canada. 

About Oneworld Accuracy (1WA)
1WA is an independent, social enterprise group headquartered in Vancouver, B.C., Canada. 1WA provides a comprehensive set of more than 200 accredited EQA programs spanning all clinical disciplines. 1WA is also a coordinator of collaborative EQA which seeks to create cost-effective, sustainable, networked EQA in all countries using 1WA’s proprietary OASYS informatics system as a shared resource. Government stakeholders including public health institutes, ministries of health, and national reference laboratories become national EQA providers on a pathway to attain their own ISO accreditation.  Upwards of 60 government stakeholders have participated in 1WA collaborative EQA to date. 1WA is accredited to ISO/IEC 17043:2010.

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 EQA program or COVID-19 QAPs, the utility or consequences of use of the EQA program or COVID-19 QAPs, references to external collaborators and 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. 

Please visit www.microbix.com or www.sedar.com for recent Microbix news and filings.

For further information from Microbix 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
 


For further information from Oneworld Accuracy please contact:
Daniel Taylor, CEO
dtaylor@1WA.org
(604) 657-0727
Simon Anderson, CFO
sanderson@1WA.org
 

Copyright © 2020 Microbix Biosystems Inc.     

Microbix®, Kinlytic®, PROCEEDx™, QAPs™, and REDx™ Controls are trademarks of Microbix Biosystems Inc.
COPAN® and FLOQSwab® are trademarks of COPAN Italia SPA
REDx™FLOQ® is a trademark of Microbix Biosystems Inc. in cooperation with COPAN Italia SPA