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Microbix Biosystems Inc
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Microbix begins supplying COVID test quality products

2020-05-06 09:19 ET - News Release

Mr. Cameron Groome reports


Microbix Biosystems Inc. 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 per week of room-temperature-stable REDx FLOQ SARS-CoV-2 swab QAPs, and 10,000 units per 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 chief executive officer, 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 QAPs are whole-genome workflow support tools that include 100 per cent 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 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 Inc.

Microbix Biosystems 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.

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