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
BiosystemsMicrobix 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 InformationThis
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:
Cameron Groome, CEO(905) 361-8910 |
Jim Currie, CFO(905) 361-8910 |
Deborah Honig, Investor RelationsAdelaide Capital Markets(647)
203-8793 ir@microbix.com |
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.
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