Sales Of QAPs™ Kits To Help Qualify Multi-Pathogen Respiratory Test Systems
MISSISSAUGA, CANADA, October 29, 2020 – Microbix Biosystems Inc. (TSX: MBX, OTCQB: MBXBF, Microbix®), a life sciences innovator and exporter, announces the availability and initial material sales of “onboarding” kits of its quality assessment products (QAPs™), designed to help testing sites with the successful installation and qualification of multi-pathogen respiratory testing systems.
Branded as “ONBOARDx™,” these QAPs kits are “RUO” classed and intended to assist labs with confirming technician proficiency, the functioning of instruments and reagents, and the handling of test samples. By so doing, ONBOARDx kits help qualify newly-purchased tests or test systems for use with patient samples.
ONBOARDx kits use Microbix’s “PROCEEDx™FLOQ®” room-temperature stable positive and negative samples, formatted on COPAN® FLOQSwabs®. PROCEEDxFLOQ swabs are available for support of each of COVID molecular tests, COVID antigen tests, and Flu A, Flu B, or RSV (each for both molecular and antigen tests). These unique and proprietary products provide important help for clinical lab directors or point-of-care sites as they work to implement multiple new or unfamiliar diagnostic tests or testing systems.
Microbix is making ONBOARDx available to test-makers directly, and to testing sites via its distributors; Alpha-Tec Systems, Inc., Diagnostic International Distribution S.p.A., Labquality Oy, The Medical Supply Company of Ireland, and R-Biopharm AG. Pathogen mix and swab numbers in kits can be customized.
Initially, more than 1,000 kits have been ordered, comprised of tens of thousands of swabs (units). This represents over CDN$ 500,000 in sales, with customer projections of continuing growth. A first material ONBOARDx shipment has now been completed, and in Q1 calendar 2021, Microbix is enhancing its FLOQSwab-based QAPs supply-chain to support production of up to 50,000 units per month.
As for all Microbix QAPs™, those in ONBOARDx kits emulate real patient samples while being consistent, non-infectious, and stable. Their broad cross-platform compatibility and guaranteed utility is particularly relevant for onboarding many different tests, instruments, and reagents under pandemic conditions.
Phil Casselli, SVP at Microbix, commented “Testing sites are working under stressful conditions – being tasked with delivering high test volumes with fatigued and diminished staff, while implementing new tests and testing systems, and using multiple reagents that can be incompatible across different testing systems. Our ONBOARDx kits enable test-makers and laboratory directors to more readily qualify new instruments, tests, or reagents for use, and to help with technician training. After successful validations by multiple industry leaders, we are now pleased to begin more broadly offering our ONBOARDx kits.”
About Microbix Biosystems
Microbix develops proprietary biological and technology solutions for human health and well-being, with about 80 skilled employees and sales growing from a base of approximately $1 million per month. 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 the quality 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.
This news release includes “forward-looking information,” as such term is defined in applicable securities laws. Forward-looking information includes, without limitation, all discussion of the ONBOARDx kits, the utility or consequences of use of the ONBOARDx kits, references to external collaborators and 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 domestic or 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.
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For further information, please contact Microbix at:
|Cameron Groome, CEO
|Jim Currie, CFO
|Deborah Honig, Investor Relations
Adelaide Capital Markets
(647) 203-8793 email@example.com