Microbix’s REDx™ Controls Attain Australian TGA RegistrationEnables Use of COVID-19 and HPV Products by Australian Clinical Labs
MISSISSAUGA, Ontario, Sept. 10, 2020 (GLOBE NEWSWIRE) -- Microbix Biosystems Inc.. (TSX: MBX, OTCQB: MBXBF, Microbix®), an award-winning life sciences innovator and exporter, is pleased to announce attainment of Australian Therapeutic Goods Administration (TGA) registration for its COVID-19 and high-risk HPV quality assessment products (QAPs™) – TGA registration of these REDx™ Controls & REDx™FLOQ® products by Microbix’s distributor, R-Biopharm, enables it to offer these workflow controls to Australian clinical labs.
Specifically, R-Biopharm Pty Ltd. has attained an Australian Register of Therapeutic Goods Certificate in compliance with the relevant national Acts and Regulations. This registration permits the sale of Microbix’s positive and negative sample workflow controls in support of testing for active COVID-19 disease in liquid vial format (REDx Controls) and on room-temperature stable dried swabs (REDxFLOQ). The registration also includes Microbix’s liquid vial format REDx Controls positives for high-risk Human Papilloma Virus (HPV) types 16, 18, 45, and corresponding negative sample.
To Microbix’s knowledge, its COVID-19 and HPV QAPs are the only third-party nucleic-acid test (NAT) workflow controls to be registered with the TGA to support the quality objectives of clinical laboratories throughout Australia and its territories. As of September 9, Australia has conducted over 6.7 million tests for COVID-19 disease and recorded over 26,000 cases (source: Worldometers).
The Microbix COVID-19 and HPV QAPs have been shown to work with multiple NAT methods used to detect the SARS-CoV-2 virus that causes COVID-19 disease, or the high-risk types of HPV that are directly implicated as the cause of multiple human cancers. As whole-genome controls, Microbix’s QAPs support test accuracy regardless of what variety of nucleic-acid sequences a test targets across the viral genome.
Cameron Groome, President and CEO, stated, “We’re pleased R-Biopharm has completed the process of registering our COVID-19 and HPV QAPs to permit their sale for test workflow support at clinical labs in Australia. Sales enquiries should be directed to R-Biopharm Australia Pty Ltd., while Microbix will be pleased to provide further technical support. We intend for our QAPs to support the accuracy of testing for COVID-19 disease and high-risk HPV infections throughout Australia and its territories, as they’re now doing in numerous other countries across the European Union, North America, Scandinavia, and the UK.”
Andreas Simons, Director of Product Management, Clinical Diagnostics for R-Biopharm also commented, “We’re pleased that clinical labs across Australia will now have access to Microbix’s superior workflow controls for supporting the accuracy of RT-PCR tests for COVID-19 and PCR tests for high-risk HPV. Technical training of R-Biopharm’s local representatives is complete, we’ve inventoried product, and we’ll now be supporting adoption of these controls to help clinical labs ensure that their testing programs minimize false negatives and false positives – each of which can result in harm to patients and society.”
About Microbix Biosystems
Microbix develops proprietary biological and technology solutions for human health and well-being, with approximately 80 skilled employees and sales 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 workflows. Microbix antigens enable the antibody tests of over 100 international diagnostics companies, while its QAPs are sold to clinical laboratory accreditation organizations, diagnostics companies, and clinical laboratories. Microbix QAPs are now available in over 20 countries, distributed by Alpha-Tec Systems, Inc., Diagnostic International Distribution S.p.A., Labquality Oy, The Medical Supply Company of Ireland, and R-Biopharm AG. Microbix is ISO 9001 and 13485 accredited, U.S. FDA registered, Australian TGA registered, Health Canada establishment licensed, and provides CE marked products.
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 treat blood clots. Microbix is publicly-traded on the TSX and OTCQB, and headquartered in Mississauga, Ontario, Canada.
About R-Biopharm AG and R-Biopharm Australia Pty Ltd.
Founded in 1988, based in Germany, and privately-owned, R-Biopharm AG is a leading global provider of test systems for clinical diagnostics, companion diagnostics, and analyzing human and animal feedstuffs. Its products are characterized by innovation, quality, reliability, and efficiency. R-Biopharm products are sold through a network of more than 20 affiliates or subsidiaries, and over 120 distribution partners. Please visit www.r-biopharm.com for more 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 COVID-19 QAPs, the utility or consequences of use of the COVID-19 QAPs, references to external collaborators and regulators or 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.
For further information, please contact Microbix at:
|Cameron Groome, CEO
|Jim Currie, CFO
|Deborah Honig, Investor Relations
Adelaide Capital Markets
(647) 203-8793 firstname.lastname@example.org
Copyright © 2020 Microbix Biosystems Inc.
Microbix®, Kinlytic®, PROCEEDx™, QAPs™, and REDx™ Controls are trademarks of Microbix Biosystems Inc.
REDx™FLOQ® is a trademark of Microbix Biosystems Inc. in cooperation with COPAN Italia SPA