Microbix Biosystems Inc (MBXBF)

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Microbix Creates Further COVID-19 Quality Assessment Products

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.