Microbix Biosystems Inc. (
TSX: MBX, OTCQX: MBXBF,
Microbix®), a life sciences innovator, manufacturer, and
exporter and Labquality Oy (
Labquality), a global
provider of laboratory external quality assessment
(“
EQA”) programs, announce their creation of the
world’s first program to support accreditation of clinical
laboratories for detecting the pathogens most commonly causing
genital ulcer disease (“
GUD”).
This novel Labquality EQA program will help
ensure the proficiency of clinical labs testing to diagnose the
pathogens that cause GUD. Initially, the program ascertains lab
competency in detecting the four pathogens that are the most common
causes of GUD – the organisms of Herpes Simplex 1 and 2 (HSV
1&2), Varicella Zoster (VZV/Chicken Pox), and Treponema
pallidum (TP/Syphilis). As the clinical presentation of these
infections can be similar, testing distinguishes between them to
better direct treatment decisions. Other GUD pathogens, such as
Mpox (Monkeypox), can be added to the program as-needed.
A Microbix fourplex quality assessment product
(“QAP™”), formatted onto a Copan® FLOQSwab®, is
used to establish the proficiency and accuracy of the GUD testing.
In turn, Labquality has designed and is managing this GUD-oriented
EQA program – which is now offered to labs in 60 countries.
The QAPs and EQA program were validated by way
of a pilot-study that involved 18 clinical laboratories in 9
countries. In the EQA rounds performed thus far, the Microbix
“PTDx™FLOQ® - HVT” QAPs were detected by 97% of the participants
using tests across different instrument/assay platforms. Full
results will be presented by Labquality or Microbix at an
appropriate industry forum over the coming months.
Juha Wahlstedt, Sales Director at Labquality,
commented, “We’re pleased to be employing Microbix’s innovative
QAPs for this new and important EQA program. Genital ulcers are the
cause of a considerable and growing burden of disease that can only
be alleviated by way of accurate diagnosis and treatment.”
Pavel Zhelev, Director of Project Management at
Microbix also commented, “We’re pleased to enable the creation of
EQA for these clinically-important diseases. Our expertise was
joined to that of Labquality and Copan to ensure accurate testing
and properly-directed treatment is widely available for GUD
patients.”
Canadian labs can enroll in this GUD EQA program
(product code 5556) via R-Biopharm Clinical Canada at
orders@r-biopharm.ca, international labs via their local Labquality
distributor or info@labquality.fi, and enquires about Microbix QAPs
can be directed to customer.service@microbix.com.
About Labquality Oy, a part of COR Group
OyBased in Helsinki, Labquality is a Finnish owned and
operated life sciences company that provides clinical laboratories
with external quality assessment (EQA) programs to evaluate their
proficiency and attain necessary accreditations. Labquality
services approximately 8,000 customers in over 60 countries and
maintains an extensive network of sub-distributors to support its
products and programs.
About Microbix Biosystems
Inc.Microbix Biosystems Inc. 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 EQA and 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 InformationThis
news release includes “forward-looking information,” as such term
is defined in applicable securities laws. Forward-looking
information includes, without limitation, discussion of GUD, the
EQA program, Labquality, Copan, or their relevance, Microbix’s
products or services, business and business results, goals or
outlook, risks associated with financial results and stability,
development projects such as those referenced in its presentations,
regulatory compliance and approvals, sales to foreign
jurisdictions, engineering and construction, production (including
control over costs, quality, quantity or timeliness of delivery),
currency exchange rates, maintaining adequate working capital or
raising new capital on acceptable terms or at all, and other
similar statements about 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.
Microbix cautions that all forward-looking information is
inherently uncertain and actual performance may be affected by a
number of material factors, many of which are beyond its 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 Microbix’s judgement as of the date of this
new release, and it 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 |
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Copyright © 2023 Microbix Biosystems Inc.
Microbix®, DxTM™, Kinlytic®, PTDx™, and QAPs™ are trademarks of
Microbix Biosystems Inc.PTDx™FLOQ® is a trademark of Microbix
Biosystems Inc. in cooperation with Copan Italia, S.p.A.Copan®,
FLOQ®, and FLOQSwab® are trademarks of Copan Italia S.p.A.
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