Microbix Achieves New QAPs Sales Record

MISSISSAUGA, Ontario, Sept. 27, 2023 (GLOBE NEWSWIRE) -- Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix^®), a life sciences innovator, manufacturer, and exporter, announces that it has secured record purchase orders (“P.Os.”) for over one million Canadian Dollars (“C$ 1 Million”) of its quality assessment products (“QAPs™”) from a leading global maker of infectious disease diagnostic tests, QuidelOrtho Corporation (“QuidelOrtho”) – for its largest set of QAPs P.Os. to date.

The P.Os. are for Microbix QAPs formatted onto Copan^® FLOQSwabs^® to support the use of point-of-care-tests (“POCTs”) for multiple infectious diseases and disease categories. The QAPs will be supplied to QuidelOrtho for two applications, (i) inclusion into kits/boxes of test consumables at a fixed ratio on a “white-label” basis and (ii) as Microbix-branded “ONBOARDx^™” kits for verification, validation, and training at new instrument-user installations. When included in kits/boxes, test-users should use a test-cartridge and the QAP every time a new box is opened – to verify operator competency, cartridge and reagent function, and instrument operation as an integral part of the POCTs’ quality management system.

The P.Os. are targeted for delivery principally in the fourth quarter of calendar 2023. This set of P.Os. is nearly equivalent to a full quarter’s worth QAPs sales from 2022 and is indicative of Microbix beginning to realize its targeted sales growth for this segment. The unit number of QAPs supplied under the P.Os. is in the tens of thousands and Microbix expects ongoing sales to QuidelOrtho, with which it executed a Purchase and Supply Agreement on August 10, 2022.

Management believes this order substantiates diagnostics industry trends that are beneficial to Microbix and its QAPs business. Specifically, that (i) there is a growing volume of POCT sales, (ii) Diagnostics makers must integrate test controls (QAPs) with their POCTs for quality management and regulatory compliance, and (iii) safe, reliable, room-temperature stable, and FLOQSwab-formatted QAPs are the optimal in-kit controls for POCTs. These trends relate to both antigen and molecular test formats, as do the P.Os.

Cameron Groome, CEO & President of Microbix, stated, “We’re delighted to advance our relationship with QuidelOrtho and support their emerging POCTs with our expertise and capabilities. We’re thankful for their confidence and look forward to the success of their diagnostic tests across the global marketplace while we continue expanding our manufacturing capacity and range of QAPs, reagents, and antigens.”

Phil Casselli, SVP of Sales and Business Development of Microbix also commented, “Over the last several years, we’ve refined our expertise and expanded our product range supporting the POCT industry. These orders are the result of those efforts. We strongly believe multi-pathogen POCTs will become more prevalent in society as they can deliver more timely results, improved access, and net cost savings. Our team is proud to be helping to enable this evolution.”

About Microbix Biosystems Inc.

Microbix Biosystems Inc. creates proprietary biological products for human health, with over 100 skilled employees and annualized sales now targeting C$ 2.0 million per month. It makes a wide range of critical ingredients and devices 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. Its antigens drive the antibody tests of approximately 100 diagnostics makers, while QAPs are sold to clinical lab accreditation organizations, diagnostics companies, and clinical labs. Microbix QAPs are now available in over 30 countries, supported by a network of 10 international distributors. Microbix is ISO 9001 & 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 viral transport medium (DxTM™) to stabilize patient samples for lab-based molecular diagnostic testing and Kinlytic^® urokinase, a biologic thrombolytic drug used to treat blood clots. Microbix is traded on the TSX and OTCQX, and headquartered in Mississauga, Ontario, Canada.

Forward-Looking 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 QuidelOrtho purchases of QAPs and their relevance, 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.

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Copyright © 2023 Microbix Biosystems Inc.

Microbix^®, DxTM^™, Kinlytic®, ONBOARDx^™, and QAPs^™ are trademarks of Microbix Biosystems Inc.

Copan^®, FLOQ®, and FLOQSwab^® are trademarks of Copan Italia S.p.A.