Microbix Biosystems Inc. (
TSX: MBX, OTCQX: MBXBF,
Microbix®), a life sciences innovator, manufacturer, and
exporter, announces a collaboration with Ulisse Biomed S.p.A.
(
BIT: UBM, Ulisse), a company developing
innovative diagnostics, theranostics, and therapeutics. The
companies are collaborating to make Microbix’s Quality Assessment
Products (“
QAPs™”) available and optimized to
support the clinical use and accuracy of Ulisse molecular tests for
high-risk types of Human Papilloma Virus (“
HPV
Assays”).
Molecular (i.e., “PCR”) HPV
Assays are used to diagnose infections and distinguish between the
virus types that generate higher or lower risks of fatal cancers.
HPV is a family of approximately 100 sub-types of virus, of which
14 are directly implicated to cause human cancers – most notably
cervical tumors. Molecular tests for high-risk types of HPV
identify at-risk patients years before cancers arise, thereby
permitting them to be carefully monitored to prevent the
development of invasive and potentially lethal tumors. However, HPV
Assays must be stringently monitored to ensure their accuracy –
ideally with Microbix QAPs.
Ulisse has obtained EU “CE mark” approval for
its high-risk extended genotype HPV Assays, which will now be
commercialized on an automated sample-to-result closed system with
an installed base of over 1,500 instruments. Moreover, Ulisse’s HPV
Assays are validated with the most widely used open platforms and
with Hyris bCUBETM, a miniaturized PCR instrument particularly
suitable for small-medium laboratories that Ulisse is proposing to
clients in conjunction with its assays. Ulisse has validated
Microbix’s HPV QAPs as tools to support the ongoing accuracy of its
HPV Assays and will recommend their usage in its instructions for
use (“IFUs”). Additionally, Microbix has created
custom ONBOARDx™ kits of QAPs to assist the Ulisse sales teams in
demonstrating the HPV Assays to prospective customers, as well as
for training operators and for qualifying new HPV Assay
installations.
Phil Casselli, SVP of Business Development at
Microbix, commented, “We met the Ulisse senior team at a conference
in Europe. Shortly thereafter we began working with them as they
finalized the performance evaluation of their assays. We are proud
to be selected as their preferred controls and to be referenced on
their IFUs. This is another success as we bring these sophisticated
high-risk HPV control products to the global markets for HPV
screening”.
Bruna Marini, COO of Ulisse, also commented, “We
were looking for a set of controls that fully covered the range of
high-risk HPV types and Microbix is the only company to have such a
portfolio. After an extensive evaluation process, we concluded the
performance of Microbix QAPs are exactly what Ulisse needs and the
interactions with their team are delightful.”
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 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.
About Ulisse Biomed S.p.AUlisse
Biomed S.p.A. is a healthcare biotech company operating in
diagnostics, theranostics and therapeutics with the mission to
develop innovative solutions in these fields. The company has three
proprietary technology platforms capable of generating innovative
and competitive products: Sagitta (molecular diagnostics),
NanoHybrid (theranostics & diagnostics), and Aptavir
(therapeutics). UBM owns a portfolio of nine patent families that
cover those three technology platforms. The core business of the
company is the design, manufacturing and distribution of assays
based on Sagitta technology which allows real-time PCR, deep
multiplexing capabilities, and high sensitivity that can be
executed even without nucleic acid extraction and purification.
Ulisse is ISO 9001 & 13485 accredited and provides CE marked
products. More information about the company is available at
https://ulissebiomed.com.
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 Ulisse and
its HPV Assays, Microbix and its QAPs, their relevance, or others’
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 many
material factors, some 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
https://www.sedarplus.ca 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®, PROCEEDx®, QAPs™, and REDx® are
trademarks of Microbix Biosystems Inc.Other companies’ names and
products are protected by their respective trademarks.
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