Cizzle Biotechnology (LON:CIZ), the UK based diagnostics developer of early cancer tests, has announced the following operational update and highlights for the six months ended 30 June 2026.
H1 2026 Highlights
· CIZ1B biomarker test successfully accredited for clinical use in the U.S., the world’s largest diagnostics market, under the Clinical Laboratory Improvement Amendments (“CLIA”).
· Delivery via a CLIA accredited laboratory marks the beginning of Cizzle Biotechnology’s commercialisation phase.
· Patent granted in the U.S., covering the Company’s core methods to measure CIZ1B strengthening protection of the Company’s core technology in one of its most important commercial markets.
· Patent granted in Canada, which together with U.S. patent protection, enhances the Company’s commercial position across North America and provides additional protection for its licensing partners as commercial activities continue to expand.
· Aggregate guaranteed minimum royalty receipts under the agreement with BIO increased to approximately US$5.9 million, reflecting BIO’s continued commitment to commercialising the CIZ1B technology in North America.
As previously announced, the Company has achieved successful laboratory accreditation of its proprietary test for the CIZ1B biomarker which is highly associated with early-stage lung cancer detection.
Cizzle continues to work closely with the Company’s North American licensing partner Cizzle Bio Inc (“BIO”) with the test approved for use under CLIA accreditation at OmniHealth Diagnostics (“OmniHealth”), a CLIA-certified, COLA-accredited clinical laboratory based in Dallas, Texas.
The Board believes that now accreditation is in place, resources and efforts with its U.S. Partner, BIO, can be focused on the marketing and deployment of the CIZ1B biomarker tests into clinics with plans to scale through multiple clinical laboratory sites including Texas, New York, California, South Carolina, Tennessee and Florida, which will provide US nationwide testing coverage. The Company is now focused on technical options to accelerate roll-out more widely.
Outlook
The Board believes that the successful achievement of CLIA accreditation marks the beginning of Cizzle Biotechnology’s commercial phase, transitioning the Company from development to commercialisation.
In addition, the Board continues to investigate and negotiate further strategic commercial partnerships and royalty bearing agreements in the UK, Europe and in the Asia-Pacific region.
It is expected that these new agreements will continue to be low cost, with minimal distribution, service or supply costs incurred by Cizzle. The Board is excited for the next stage of the Company’s growth as it moves from the validation phase to the commercialisation phase, which the directors believe, significantly de-risks the business.
The Board looks forward to providing further updates in due course.
Commenting, Allan Syms, Executive Chairman of Cizzle Biotechnology, said:
“The first half of 2026 represents probably the most important period in Cizzle’s development since the Company was founded. Our focus has been on transitioning from technology development and validation to commercial deployment, and we have delivered significant milestones towards that objective.
“Most notably, the achievement of CLIA accreditation for our CIZ1B biomarker test represents the point at which our proprietary technology can begin to be used in routine clinical practice in the United States. This is a major validation of both the science underpinning our technology and the significant work undertaken alongside our licensing partner BIO.
“Alongside this commercial progress, we have continued to strengthen our intellectual property position with important patent grants in both Canada and the United States, reinforcing the long-term value of our cancer detection technology.
“With U.S. regulatory approval achieved, a strengthened patent portfolio and enhanced long-term commercial arrangements in place, we believe the Company is well positioned to support the launch and expansion of the CIZ1B test within the U.S. market while now focussing efforts on commercial opportunities in the UK and more widely.”
