Mr. Cameron Groome reports
MICROBIX CREATES QUALITY ASSESSMENT PRODUCT FOR COVID-19 TESTS
Microbix Biosystems Inc. has created, verified and will soon make commercially available a quality assessment product (QAP) to help ensure the accuracy of COVID-19 disease testing.
By creating this unique product, Microbix is contributing to the development of new methods and improved methods for SARS-CoV-2 virus (COVID-19) detection and is helping to improve the accuracy of existing protocols by providing reliable, whole-genome validation/verification and training samples.
Microbix currently has capacity to make 5,000 units per week of room-temperature stable COVID-19 QAPs exclusively on COPAN FLOQSwabs, with a liquid-format COVID-19 QAP also available. Such QAPs can be shipped immediately to support the verification of new testing methods, the validation of newly placed test instruments, the training of technicians, and the attainment of laboratory proficiency accreditations. Further regulatory authorizations will be sought on an emergency-use basis, and when granted, will permit the release of IVD-labelled versions of Microbix's COVID-19 products for continuing quality management system (QMS) support of clinical laboratories. By way of example, at usage of one per hundred tests, such QAPs would help ensure the accuracy of 500,000 COVID-19 tests per week.
Cameron Groome, president and chief executive officer, stated: "We're pleased to be able to immediately offer assistance to health professionals in the global fight against this recently emerged pandemic. Microbix is grateful to our staff and external collaborators for their work in creating and validating this essential product so quickly. We also want to provide a message of heartfelt thanks and support to our friends at COPAN Italia, who are enduring so much while working 24-seven to provide their vital sample collection swabs to hospitals and labs around the world."
This new and innovative Microbix product has been shown to work with nucleic-acid based test (NAT) methods used to detect the SARS-CoV-2 virus that causes COVID-19 disease, specifically that published by the U.S. Centers for Disease Control (run at MBX) and of Seegene Inc. (Allplex 2019-nCoV assay, run externally at KoronaDx). Microbix will now file for emergency-use authorizations from Health Canada, the U.S. Food and Drug Administration (FDA), and other regulatory authorities, while concurrently conducting further external verifications across more of the test platforms now in use. Once authorizations are received, the products will be made available as REDxFLOQ SARS-CoV-2 for swabs and as REDx Control SARS-CoV-2 for liquid aliquots.
As for all Microbix QAPs, this COVID-19 product is a whole-genome workflow support tool that includes 100 per cent of the genetic sequences of the virus and emulates real patient samples while being consistent, non-infectious and stable. As such, it contains all possible NAT viral targets -- ensuring compatibility across all current and future NATs. This broad compatibility and guaranteed utility is particularly relevant for external quality assurance programs that assess and ensure the performance of testing labs.
Microbix supplies a broad range of white-labelled QAPs, including other viral respiratory pathogens, to support the proficiency testing (PT) programs of laboratory accreditation organizations in North America and Western Europe. 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 FDA-registered and CE mark certified REDx Control brand QAPs.
About Microbix Biosystems Inc.
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.
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