12/02/2019 | Press release | Archived content
MISSISSAUGA, December 2, 2019 - Microbix Biosystems Inc. (TSX: MBX, Microbix®), a life sciences innovator making critical ingredients that enable the production of clinical diagnostics and creating medical devices that help ensure test accuracy, announces it has been invited to present the performance of its in-vitro diagnostics (IVD) quality products 'IVD Controls' at EUROGIN 2019, the annual congress of the European Research Organization on Genital Infection & Neoplasia.
At EUROGIN, Microbix will be exhibiting alongside leading IVD and pharmaceutical companies working on prevention and detection of Human Papilloma Virus (HPV) infection. The majority of sexually-active adults are infected with one or more types of HPV and the high-risk variants of the virus are a well-known and common cause of multiple human cancers. Tests to establish whether individuals are infected with a high-risk type of HPV provide important health information and require validated, regulated, and third-party IVD Controls to help ensure their accuracy. Microbix has created IVD Control products that support tests for high-risk HPV types 16, 18, & 45, and cleared them for sale in both the European Union (via CE mark) and the United States under its REDx™ Controls brand name.
Microbix will also review the performance of those novel, proprietary, and branded IVD Controls to support quality control of nucleic acid amplification tests (NAATs) for high-risk types of HPV. Its presentation is entitled 'Novel Cross-Platform High-Risk (HR) HPV NAAT Positive Controls for Use in L1 and E6/E7 Targeted Nucleic Acid (DNA and RNA) Detection Methods' and establishes that Microbix's REDx Controls for HPV tests contain all required diagnostic targets, support all test steps, and are compatible across the leading NAAT testing instrument platforms. A well-designed IVD Control should work with any test equipment, just like a patient sample. Microbix believes its REDx Control results support the quality objectives of clinical labs testing for high-risk HPV infections, will assist with the provision of effective healthcare globally, and represent meaningful new revenue opportunities.
This scientific 'poster' was authored by Microbix's development team, provides new performance results in a complete and succinct fashion, and is being presented by its Director of Quality Assessment Products (QAPs™), Pavel Zhelev, supported by its SVP of Sales & Business Development, Phillip Casselli. The full poster will be made available on the company website (www.microbix.com) and by EUROGIN following its presentation and includes Microbix's thankful acknowledgement of its collaborators.
Microbix's REDx Controls, are highly representative of patient samples, provide safe and reliable means of monitoring the laboratory workflow and performance accuracy of complex medical tests and, where relevant, work across both immunologic and NAAT test methods. Microbix's QAPs are provided to (i) laboratory accreditation organizations to support their proficiency testing programs, (ii) test makers to support product development, instrument validation and technician training, and (iii) clinical laboratories, as regulated medical devices to support their quality management systems.
Microbix develops proprietary biological and technology solutions for human health and well-being, with sales now exceeding $1 million per month and 80 skilled employees. 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 also applies its biological expertise and infrastructure to create other proprietary new products and technologies. Currently it is has two; (1) Kinlytic® urokinase, a biologic thrombolytic drug used to treat blood clots and (2) LumiSort™ cell-sorting, a technology platform for ultra-rapid and efficient sorting of cells or other particles.
Microbix is a publicly-traded company, listed on the Toronto Stock Exchange and headquartered in Mississauga, Ontario, Canada.
Started in 1993 as a congress where scientific progress and clinical practice converge, EUROGIN shares translational research with an international scientific community, aiming at accelerating the reduction of the burden of HPV-related cancers and their mortality. The EUROGIN Educational Platform on HPV-Associated Cancers offers a high standard of scientific contents provided by top international experts to extend knowledge and share experience, for the purposes of advancing science and translational research, as well as ensuring best clinical practices.
This news release includes 'forward-looking information,' as such term is defined in applicable securities laws. Forward-looking information includes, without limitation, discussion of EUROGIN and the results presentation, the content, meaning or consequences of the results presentation, 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.
Please visit www.microbix.com or www.sedar.com for recent Microbix news and filings.
For further information, please contact Microbix at:
Cameron Groome, CEO
Jim Currie, CFO
Deborah Honig, Investor Relations
Adelaide Capital Markets
(647) 203-8793 [email protected]