REG - Cizzle Biotechnology - Update on Launch of CIZ1B Biomarker Assay

Cizzle Biotechnology HoldingsAnnouncement

24/03/2025 07:00

For best results when printing this announcement, please click on link below:
https://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20250324:nRSX7931Ba&default-theme=true

RNS Number : 7931B  Cizzle Biotechnology Holdings PLC  24 March 2025

THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF
EU REGULATION 596/2014 (WHICH FORMS PART OF DOMESTIC UK LAW PURSUANT TO THE
EUROPEAN UNION (WITHDRAWAL) ACT 2018 ("EUWA")) ("UK MAR")

24 March 2025

Cizzle Biotechnology Holdings plc

 

("Cizzle", "Cizzle Biotechnology", or the "Company")

 

First COLA and CLIA Accredited Laboratory in USA confirmed

Update on Launch of CIZ1B Biomarker Assay

Cizzle Biotechnology, the UK based diagnostics developer of early cancer
tests, is pleased to announce that its licensing partner Cizzle Bio Inc ("BIO"
or "Cizzle Bio") has appointed iGenomeDX, a specialist clinical diagnostics
laboratory to launch the Company's first commercial CIZ1B biomarker test in
the USA.  iGenomeDX is a Commission on Office Laboratory Accreditation
("COLA") accredited and Clinical Laboratory Improvement Amendments ("CLIA")
certified clinical laboratory and has been establishing operating and quality
systems ahead of offering the test to clinicians for the first time.

 

Key Highlights

 

·    iGenoneDX appointed by BIO as first clinical diagnostics laboratory
to offer commercial CIZ1B biomarker testing.

 

·    This follows successful collaboration and support between Cizzle,
iGenomeDX and BIO to complete an operational and quality systems programme
designed to meet the exacting standards required in iGenomeDX's COLA
accredited, CLIA certified laboratory, designated to validate CIZ1b as a
laboratory developed test for commercial use ahead of the launch of the CIZ1B
biomarker test.

 

Background

 

On 21 October 2024 the Company announced an exclusive licensing and
partnership agreement with BIO for its proprietary CIZ1B biomarker test to
help detect early-stage lung cancer, throughout the USA and Canada.  The
Company has since received payments of US$400,000 due from initial exclusivity
fees and advanced royalties as part of guaranteed payments totalling US$2.4
million over the period ending April 2027.  The Company has now extended that
agreement, as announced on 16 December 2024, to cover the 14 Sovereign States
of the Caribbean and the Cayman Islands ("Caribbean") triggering early
payments totalling US$250,000 in July 2025 and US$250,000 in September 2025.

 

The appointment of iGenomeDX by BIO, a specialist clinical diagnostics
laboratory, is the next step in the Company's plan to achieve commercial sales
later this year by providing an accredited facility to launch the CIZ1B
biomarker test.  The accreditation process involved an evaluation of a
laboratory's operations, including its testing procedures, quality control,
personnel qualifications, and compliance with regulatory requirements.  Labs
that achieve COLA accreditation demonstrate a commitment to maintaining high
standards of accuracy, reliability, and patient safety in diagnostic testing
to ensure they meet CLIA standards and can legally operate.

 

The successful completion of the operational and quality systems programme is
necessary for launching a cost-effective and scalable version of the CIZ1B
biomarker assay with rigorous quality control requirements to meet expected
reproducibility and sensitivity.  This will demonstrate the test is
commercially scalable and can be rolled out as a global solution to help
reduce premature cancer deaths and improve survival rates and quality of life
for cancer patients.

 

Commenting, Allan Syms, Executive Chairman of Cizzle Biotechnology, said:

 

"I am delighted to announce the positive progress being made by our partners
Cizzle Bio who have appointed the first of their COLA and CLIA accredited
clinical diagnostics laboratories to bring our CIZ1B Biomarker test for
early-stage lung cancer to market.  In the short time since we began our
exclusive licensing partnership with Cizzle Bio, they have initiated multiple
ongoing partnerships with several National Cancer Institute (NCI) designated
cancer centres throughout the United States, with the goal of enhancing early
detection capabilities for lung cancer.  They have strengthened their
leadership team with industry and clinical expertise and in creating the
launchpad for our CIZ1B biomarker test.  In collaboration with Cizzle Bio we
continue to work closely with iGenomeDX's exceptional leadership and technical
team to ensure a seamless transition of technology into the clinic.  We look
forward to sharing updates on their first commercially available tests in the
near future."

 

Enquiries:

 

 Cizzle Biotechnology Holdings plc  Via IFC Advisory
 Allan Syms (Executive Chairman)

 

 Allenby Capital Limited                                       +44(0) 20 3328 5656
 John Depasquale / Piers Shimwell (Corporate Finance)
 Stefano Aquilino / Amrit Nahal (Sales and Corporate Broking)

 

 IFC Advisory Limited            +44(0) 20 3934 6630
 Tim Metcalfe
 Florence Chandler

 

About Cizzle Biotechnology

 

Based on the pioneering work of Professor Coverley and colleagues, on a
naturally occurring variant of the cell nuclear protein CIZ1, the CIZ1B
biomarker is highly associated with the presence of early-stage cancer. The
company has developed CIZ1B into a non-invasive, cost-effective blood test to
help in the early detection of lung cancer and has now entered commercial
royalty-bearing arrangements to license its proprietary technology, and into
collaborations with centres of excellence in cancer care.  Cizzle was
admitted to the Standard segment of the main market of the London Stock
Exchange in May 2021.

 

For more information, please see https://cizzlebiotechnology.com
(https://cizzlebiotechnology.com)

 

You can also follow the Company through its twitter account @CizzlePlc and on
LinkedIn.

 

About Cizzle Bio

 

Cizzle Bio Inc, a company registered in Texas USA, stands at the forefront of
biotechnological innovation, dedicated to revolutionizing the detection of
lung cancer through groundbreaking diagnostic tools. With exclusive rights to
detect the CIZ1B Biomarker in the USA and Canada, we are driven by a
commitment to improve early cancer detection and enhance patient outcomes.

 

For more information, please see https://cizzlebio.com (https://cizzlebio.com)

 

About iGenomeDX

iGenomeDx is a COLA accredited and CLIA certified clinical diagnostics company
based in San Antonio, Texas meeting U.S. federal standards that ensures
quality and reliability in laboratory testing for human specimens. Their
mission is to enhance physician decision-making, improve patient care, and
reduce healthcare costs by providing reliable genetic testing services.
iGenomeDx offers pharmacogenomic tests to help physicians personalize
medication choices and dosages based on an individual's genetic makeup, as
well as molecular diagnostics for infectious diseases such as respiratory,
urinary tract, wound, and nail infections. They also provide therapeutic drug
monitoring to assess medication adherence.

 

For more information, please see https://igenomedx.com (https://igenomedx.com)

 

 

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  MSCUOUWRVVUOUAR