Microbix Biosystems Inc. (
TSX: MBX, OTCQX: MBXBF,
Microbix®), a life sciences innovator, manufacturer, and
exporter, announces it is presenting about the utility of its
multi-pathogen (“
multiplex”) and swab-formatted
Quality Assessment Products (“
QAPs™”) to monitor
molecular assays that detect and distinguish between four
sexually-transmitted infections (each an “
STI”)
that cause Genital Ulcer Disease (“
GUD”) – at the
2022 conference of the American Association of Clinical Chemistry
(“
AACC”) taking place in Chicago, Illinois from
July 24-28, 2022.
Its poster presentation is titled “Novel Herpes
Simplex Virus, Varicella Zoster Virus, and Treponema pallidum
Quality Control Material for use with Genital Lesion Molecular
Detection Assays.” The poster details the use of Microbix’s
PROCEEDx™FLOQ® HSV1&2/VZV/Syphilis Swab Positive Sample QAPs to
monitor the performance, procedures, and workflows of molecular
assays that detect STIs from the oral and genital types of the
Herpes Simplex Virus (“HSV 1” and
“HSV2”), Varicella Zoster Virus
(“VZV”) and Treponema pallidum (the spirochete
bacteria causing “Syphilis”). The PROCEEDxFLOQ
QAPs proved compatible with 13 molecular assays across both
commercially-available diagnostic platforms and
laboratory-developed tests, and were used to support an external
quality assessment pilot study.
These assessments were coordinated by the
Microbix team and consolidated data provided from 16 laboratories,
notably including the Cadham Manitoba Provincial Laboratory
(Winnipeg, Canada) and Labquality Ltd. (Helsinki, Finland), the
support of which are gratefully acknowledged.
GUDs are a current and growing global health
concern, with over 20 million new cases each year. Traditionally,
diagnosis of GUD has relied on clinical assessment of symptoms,
which lacks specificity given the similar appearance of ulcers
caused by different etiological agents. Such non-specific diagnosis
leads to misclassification, delayed treatment, and the development
of complications. Although there is now a growing pipeline of
molecular assays for sensitive and specific diagnosis of GUD,
external quality control materials to verify performance have been
largely unavailable. Microbix has overcome challenges in
formulation and appears to be the first to develop a multiplex
whole-workflow control for GUD assays. This STI-oriented
PROCEEDxFLOQ multiplex QAP adds to Microbix’s expanding portfolio,
which includes Health Canada, U.S. FDA, EU “CE mark,” or TGA
(Australia) in-vitro-diagnostic (“IVD”) regulated
REDx™ and research-use-only (“RUO”) PROCEEDx™ SKUs
across both liquid-vial and Copan FLOQSwab® formats.
Further information about Microbix’s QAPs and
its services offerings is available at
https://microbix.com and purchase enquiries for QAPs™ can be
e-mailed to customer.service@microbix.com.
About Microbix
BiosystemsMicrobix creates proprietary biological products
for human health, with over 100 skilled employees and sales
approaching 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 over 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, 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 AACC, the
poster or its relevance, the products of Microbix or its
collaborators, 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 |
Jim Macdonald,Investor RelationsTorrey Hills Capital(858)
456-7300jm@sdthc.com |
Copyright © 2022 Microbix Biosystems Inc.
Microbix®, DxTM™, Kinlytic®, PROCEEDx™, QAPs™, and REDx™ are
trademarks of Microbix Biosystems Inc.PROCEEDx™FLOQ® is a trademark
of Microbix Biosystems Inc. in collaboration with Copan Italia
S.p.A.Copan®, FLOQ®, and FLOQSwab® are trademarks of Copan Italia
S.p.A.
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