MISSISSAUGA, Ontario, May 07, 2020 (GLOBE NEWSWIRE) — Microbix Biosystems Inc. (TSX: MBX, Microbix®), an award-winning life sciences innovator and exporter, is pleased to announce U.S. availability of its SARS-CoV-2 quality assessment products (QAPs™) – FDA registration enabling immediate usage by U.S. clinical laboratories to evaluate performance, procedures, and workflow of tests that detect SARS-CoV-2 virus, the causative agent of COVID-19 disease.
Microbix has registered with the U.S. Food and Drug Administration (FDA) in compliance with Code of Federal Regulations 21, Part 807, augmenting its existing Establishment Registration #3007652384. This permits sale of its SARS-CoV-2 Positive and Negative Controls throughout the U.S. and its territories.It has been widely reported that the recently-deployed tests for the virus causing COVID-19 disease are providing results of questionable accuracy – sometimes giving “false negative,” or “false positive” results. Microbix’s SARS-CoV-2 QAPs are designed to increase the reliability of nucleic-acid test (NAT) results. These Microbix QAPs can be used to support verification of new testing methods, validation of newly-placed test instruments, training of technicians, lab proficiency accreditations, and by clinical labs for systematic quality control. Cameron Groome, President and CEO, stated, “We’re pleased to have completed the process of registering our SARS-CoV-2 Controls to permit their sale as controls to clinical labs in the United States. Microbix will now engage with American laboratory chains, group purchasing organizations, and procurement agencies to make certain that the U.S. healthcare system can benefit from Microbix’s products that help to ensure test accuracy.”The Microbix COVID-19 QAPs have been shown to work with multiple 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. These Microbix products are being made available as REDx™FLOQ® SARS-CoV-2 for swabs, and as REDx™ SARS-CoV-2 for liquid aliquots.As for all Microbix QAPs, these COVID-19 QAPs are whole-genome workflow support tools that include 100% of the genetic sequences of the virus and emulate real patient samples while being consistent, non-infectious, and stable. As such, the COVID-19 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 the proficiency testing (PT) programs of laboratory 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™ Controls or REDx™FLOQ® brand QAPs.About Microbix Biosystems
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 ISO 9001 and 13485 accredited, FDA and Health Canada establishment licensed, and provides CE marked products.
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