Microbix Launches QAP to Support “Monkeypox” Testing

MISSISSAUGA, Ontario, Jan. 30, 2023 (GLOBE NEWSWIRE) — Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix^®), a life sciences innovator, manufacturer, and exporter, announces that it is launching a new quality assessment product (“QAP™”) to support molecular diagnostic (“MDx”) testing for the Non-Variola Orthopoxvirus (“Mpox”), the cause of the cutaneous infection colloquially-known as “Monkeypox.”

From traditional low-level incidence in Central and Western Africa, incidence of Mpox surged meaningfully within many countries in 2022, leading to increased testing for this virus. However, transmission of this virus currently requires close or prolonged contact between individuals, limiting its pandemic potential.

Microbix chose to create a QAP to support Mpox testing following requests from its customers that provide proficiency-testing and accreditation services to clinical laboratories (i.e., “PT” or “EQA” providers) and to prepare for the inclusion of Mpox in standard worldwide genital ulcer disease diagnostic programs. Although the frequency of testing for Mpox is currently limited, labs must become and remain accredited for such testing by PT/EQA providers. Microbix will be providing Mpox QAPs in liquid or FLOQSwab^® formats for that PT/EQA need and as a result, its sales are not expected to be correlated to the rates of Mpox infection or with how much this virus is the subject of news media coverage.

In otherwise healthy persons, Mpox infection is usually self-limiting and non-fatal in nature. However, Mpox viral DNA has been detected in human blood, which raises the question of whether blood-borne transmission is a possibility with this emerging pathogen. If blood-borne transmission of Mpox is proven at any future time, the need for routine screening of blood and blood products could arise.

In collaboration with its PT/EQA partners, the Microbix Mpox QAP has now been validated for use across 11 leading MDx testing systems and multiple Lab Developed Tests, at 33 clinical laboratories in multiple European and Scandinavian nations. The Mpox QAP validation results may be presented by Microbix or its collaborators at a future scientific conference, in accordance with industry practices and standards. PT/EQA shipments of the Mpox QAP can now commence and Microbix expects material sales of this product starting in its current fiscal year.

Pavel Zhelev, Microbix’s Director of Product Management, remarked, “Microbix’s Mpox QAPs contain a whole viral genome that includes each primer sequence targeted by leading commercial (IVD) tests and known lab-developed assays. Our proprietary formulation and consensus genome is thereby targeted to provide lasting support for MDx Mpox tests and future support for extended genital ulcer disease panels including this pathogen, even if this virus continues to mutate at a relatively fast rate.”

Purchase enquiries for QAPs can be directed to Microbix via customer.service@microbix.com.

About Microbix Biosystems

Microbix creates proprietary biological products for human health, with over 100 skilled employees and annualized sales 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 laboratory accreditation organizations, diagnostics companies, and clinical laboratories. Microbix QAPs are now available in over 30 countries, distributed by 1WA (Oneworld Accuracy Inc.), Alpha-Tec Systems, Inc., Diagnostic International Distribution SpA., Labquality Oy, The Medical Supply Company of Ireland, Neo-Science Equipment LLC, R-Biopharm AG, SDT Molecular Pte Ltd, Seegene Canada Inc., and Thomas Scientific LLC. 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 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 Mpox, Microbix collaborators, any MDx screening programs, MDx testing for Mpox or its relevance, the products or services of Microbix, 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 or 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 https://microbix.com or www.sedar.com for recent Microbix news and filings.

For further information, please contact Microbix at:

Copyright © 2023 Microbix Biosystems Inc.

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

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

MISSISSAUGA, Ontario, Jan. 30, 2023 (GLOBE NEWSWIRE) — Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix^®), a life sciences innovator, manufacturer, and exporter, announces that it is launching a new quality assessment product (“QAP™”) to support molecular diagnostic (“MDx”) testing for the Non-Variola Orthopoxvirus (“Mpox”), the cause of the cutaneous infection colloquially-known as “Monkeypox.”

From traditional low-level incidence in Central and Western Africa, incidence of Mpox surged meaningfully within many countries in 2022, leading to increased testing for this virus. However, transmission of this virus currently requires close or prolonged contact between individuals, limiting its pandemic potential.

Microbix chose to create a QAP to support Mpox testing following requests from its customers that provide proficiency-testing and accreditation services to clinical laboratories (i.e., “PT” or “EQA” providers) and to prepare for the inclusion of Mpox in standard worldwide genital ulcer disease diagnostic programs. Although the frequency of testing for Mpox is currently limited, labs must become and remain accredited for such testing by PT/EQA providers. Microbix will be providing Mpox QAPs in liquid or FLOQSwab^® formats for that PT/EQA need and as a result, its sales are not expected to be correlated to the rates of Mpox infection or with how much this virus is the subject of news media coverage.

In otherwise healthy persons, Mpox infection is usually self-limiting and non-fatal in nature. However, Mpox viral DNA has been detected in human blood, which raises the question of whether blood-borne transmission is a possibility with this emerging pathogen. If blood-borne transmission of Mpox is proven at any future time, the need for routine screening of blood and blood products could arise.

In collaboration with its PT/EQA partners, the Microbix Mpox QAP has now been validated for use across 11 leading MDx testing systems and multiple Lab Developed Tests, at 33 clinical laboratories in multiple European and Scandinavian nations. The Mpox QAP validation results may be presented by Microbix or its collaborators at a future scientific conference, in accordance with industry practices and standards. PT/EQA shipments of the Mpox QAP can now commence and Microbix expects material sales of this product starting in its current fiscal year.

Pavel Zhelev, Microbix’s Director of Product Management, remarked, “Microbix’s Mpox QAPs contain a whole viral genome that includes each primer sequence targeted by leading commercial (IVD) tests and known lab-developed assays. Our proprietary formulation and consensus genome is thereby targeted to provide lasting support for MDx Mpox tests and future support for extended genital ulcer disease panels including this pathogen, even if this virus continues to mutate at a relatively fast rate.”

Purchase enquiries for QAPs can be directed to Microbix via customer.service@microbix.com.

About Microbix Biosystems

Microbix creates proprietary biological products for human health, with over 100 skilled employees and annualized sales 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 laboratory accreditation organizations, diagnostics companies, and clinical laboratories. Microbix QAPs are now available in over 30 countries, distributed by 1WA (Oneworld Accuracy Inc.), Alpha-Tec Systems, Inc., Diagnostic International Distribution SpA., Labquality Oy, The Medical Supply Company of Ireland, Neo-Science Equipment LLC, R-Biopharm AG, SDT Molecular Pte Ltd, Seegene Canada Inc., and Thomas Scientific LLC. 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 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 Mpox, Microbix collaborators, any MDx screening programs, MDx testing for Mpox or its relevance, the products or services of Microbix, 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 or 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 https://microbix.com or www.sedar.com for recent Microbix news and filings.

For further information, please contact Microbix at:

Copyright © 2023 Microbix Biosystems Inc.

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

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