Cizzle Biotechnology secures first commercial deployment of proprietary CIZ18 test in the world’s largest healthcare market. 

• 2 million Americans now eligible for annual lung cancer screening
• 234,000+ new lung cancer cases diagnosed in the US every year
• 90% five-year survival rate when lung cancer is detected at Stage 1

London, 16 June 2026 (LSE: CIZ) – Cizzle Biotechnology Holdings Plc, the UK-based early cancer diagnostics company, is pleased to announce it has achieved a major commercial milestone after its proprietary CIZ1B lung cancer blood test was approved for use under Clinical Laboratory Improvement Amendments (CLIA) accreditation at OmniHealth Diagnostics in Dallas, Texas. The approval enables licensed healthcare providers across the United States to order the test and establishes a regulated route to market in the world’s largest healthcare economy.

The milestone marks the first commercial deployment of Cizzle’s technology and follows decades of research led by Professor Dawn Coverley at the UK’s University of York, where the CIZ1B protein variant was first identified and linked to early-stage lung cancer. More than 14.2 million Americans are now eligible for annual lung cancer screening, yet uptake remains low, with only 18.7% of eligible individuals currently undergoing screening.

Lung cancer remains the leading cause of cancer-related deaths in the United States, claiming more lives each year than breast, prostate and colorectal cancers combined. More than 234,000 Americans are diagnosed annually, yet many cases are not identified until the disease has reached an advanced stage because symptoms are easily mistaken for other illnesses. At this point, treatment options become limited and survival rates are low.

The CIZ1B test uses a proprietary two-step ELISA format to detect a protein biomarker strongly associated with early-stage lung cancer from a simple blood sample. It is designed to complement existing screening pathways, including low-dose CT scans, helping support earlier diagnosis when treatment outcomes are significantly improved. Unlike many multi-cancer early detection tests that rely on signals in circulating tumour DNA that are difficult to identify in early-stage disease, CIZ1B measures a stable tumour-associated protein biomarker that is linked to lung cancer at its earliest stages.

Why this matters:

• Lung cancer kills more people than breast, prostate and colorectal cancers combined
• More than 14.2 million Americans are eligible for annual lung cancer screening, but only 18.7% currently undergo screening
• Most cases are diagnosed late, when five-year survival rates fall to around 10%
• Detection at Stage I can increase five-year survival rates to as high as 90%
• The test requires only a small blood sample and is designed to be cost-effective and scalable
• CLIA accreditation establishes the first regulated pathway for healthcare providers to offer the test to patients
• The approval provides a platform for expansion into the UK, Europe and Asia through Cizzle’s licensing model

The commercial milestone follows continued strengthening of Cizzle’s intellectual property portfolio. Earlier this month, the Company announced that a patent application covering its methods for detecting the CIZ1B lung cancer biomarker had been allowed by the U.S (USPTO) and Canadian Patent and Trademark Office, adding further protection for the technology in a key target market.

CLIA accreditation was achieved in partnership with North American licensing partner Cizzle Bio Inc. and OmniHealth Diagnostics, a CLIA-certified and COLA-accredited clinical laboratory. Validation at OmniHealth confirms the test’s analytical performance and operational readiness for clinical use, providing a scalable platform for wider deployment across the United States.

Professor Dawn Coverley, Founder and Chief Scientific Officer of Cizzle Biotechnology, said: “After years of work by dedicated scientists here in York, seeing the CIZ1B test finally move from bench to clinic is wonderful. We hope that its many practical advantages over other methods, including low cost and the need for very small quantities of blood, will mean that its use can be expanded into rapid and regular screening for lung cancer.”

Allan Syms, Executive Chairman of Cizzle Biotechnology, said: “CLIA accreditation for our CIZ1B biomarker test is a major milestone for the Company. This was rightly a rigorous process to demonstrate the test is reliable and accurate and can now be used in licensed clinical laboratories as an important tool to help detect lung cancer early and save lives.”

Having successfully achieved accreditation and the first commercial launch deployment of its UK-developed CIZ1B technology in the world’s largest healthcare market, the Company will continue to pursue commercial partnerships across the UK, Europe and Asia as part of its global licensing strategy, creating additional opportunities for licensing and royalty revenue.