13 Nov 2023
![NEW COLLABORATION BETWEEN ULISSE BIOMED AND MICROBIX](/userfiles/news/img/2_new-collaboration-between-ulisse-biomed-and-microbix_29.png)
Microbix & Ulisse Biomed Collaborate on HPV Controls & Assays (original press release)
Onboarding Tools and Quality Controls for Extended Genotype HPV Assays
MISSISSAUGA, Ontario and TRIESTE, Italy, Nov. 10, 2023 (GLOBE NEWSWIRE) -- 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 {nalized
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 highrisk
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
pro{ciency testing, enable assay development and validation, or help ensure the quality of clinical
diagnostic work|ows. 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.A
Ulisse Biomed S.p.A. is a healthcare biotech company operating in diagnostics, theranostics and
therapeutics with the mission to develop innovative solutions in these {elds. 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 puri{cation. Ulisse is ISO 9001 & 13485
accredited and provides CE marked products. More information about the company is available at
https://ulissebiomed.com.
Forward-Looking Information
This news release includes “forward-looking information,” as such term is de{ned 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 {nancial 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 re|ect
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 {lings.
For further information, please contact Microbix at:
Cameron Groome,
CEO
(905) 361-8910
Jim Currie,
CFO
(905) 361-8910
Deborah Honig,
Investor Relations
Adelaide 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.