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.

The Power of Early Detection. 

On World Cancer Day, the global focus is on improving cancer outcomes through earlier diagnosis, effective treatment pathways and sustained collaboration across healthcare systems. Early detection remains one of the most effective ways to improve survival, particularly as diagnostic technologies continue to advance and create new opportunities to identify cancer at a treatable stage.

At Cizzle Biotechnology, this focus underpins the Company’s work. Detecting cancer earlier can significantly improve patient outcomes and reduce the burden on healthcare systems, making innovation in diagnostics a critical part of the wider cancer strategy.

A national focus on finding cancer sooner

The NHS National Cancer Plan for England sets out one of the most ambitious cancer strategies in recent years. By 2028, the plan aims to increase the proportion of cancers diagnosed at stages 1 and 2 from around half today to three-quarters, a shift expected to save 55,000 additional lives per year.

The plan prioritises improved access to diagnosis and treatment, increased awareness of cancer symptoms, and expanded screening through more personalised and risk-stratified approaches. This policy direction reinforces the importance of earlier diagnosis and creates a strong environment for diagnostic technologies that support earlier identification of disease and more targeted screening strategies.

This framework creates significant opportunity for innovative diagnostic technologies that can support earlier detection and more targeted screening pathways.

Lung cancer: an urgent need for earlier diagnosis

Lung cancer remains one of the most significant challenges in oncology and is the leading cause of cancer-related death globally. Late diagnosis is the primary driver of poor outcomes, with many patients identified only once the disease has reached an advanced stage. The contrast is stark: five-year survival rates can reach 80–90% for early-stage lung cancer, compared with less than 10% for late-stage disease.

Blood-based biomarker tests have the potential to improve this picture. Our work focuses on developing diagnostic tests to support the early detection of lung cancer, with initial development centred on the CIZ1B biomarker, created in collaboration with the University of York. The objective is to provide a minimally invasive approach that aligns with national screening priorities and supports earlier clinical intervention.

Recently, patent applications claiming protection for methods that measure the CIZ1B lung cancer biomarker were granted by the Canadian Intellectual Property Office. The patent relates to a two-step test format and complements existing patent protection elsewhere in the world. .

The test format is licensed to Cizzle Bio, Inc. for use in North America and the Caribbean, strengthening its position as commercialisation progresses. In parallel, the Company is focused on securing partnerships with accredited facilities in the UK and Europe, including the NHS, to support clinical validation and future adoption.

United by a shared mission

World Cancer Day reflects the principles of the World Cancer Day 2025–27 campaign, “United by Unique,” which places people at the centre of care and emphasises the importance of collective action to improve cancer outcomes. Progress against cancer depends on effective collaboration across research, healthcare systems, industry and policy, with each playing a distinct and complementary role.

As activity continues across intellectual property, partnerships and market preparation, Cizzle Biotechnology remains focused on building long-term value through technologies designed to support earlier cancer detection and deliver meaningful improvements in patient outcomes.

Understanding the Deadly Cancer Gap

Over the past 40 years, cancer survival rates have improved significantly for some cancers, including breast, prostate and melanoma. Advances in research, screening and treatment have transformed outcomes and saved countless lives.

Yet this progress has not been shared equally. Six cancers, lung, pancreatic, liver, brain, oesophageal and stomach, remain just as deadly today as they were decades ago. Together, these less survivable cancers account for around half of all deaths from common cancers, despite representing only a quarter of diagnoses.

For patients, the reality is stark. The average five-year survival rate across these cancers is just 16%, meaning only one in six people diagnosed will still be alive five years later. This disparity is known as the deadly cancer gap.

The Lung Cancer Challenge

Among these cancers, lung cancer represents both the greatest challenge and the greatest opportunity for change. It is one of the most commonly diagnosed cancers worldwide and remains the leading cause of cancer death in the UK.

The reason is tragically simple: lung cancer is often detected too late. Early-stage lung cancer typically causes few or no symptoms, meaning many people are only diagnosed once the disease has progressed to an advanced stage, where treatment options are limited and outcomes are poor.

The Power of Early Detection

The contrast between early and late diagnosis could not be clearer. When lung cancer is caught at Stage 1, five-year survival rates can reach 70–90%. By Stage 4, survival falls to below 10%.

This dramatic difference highlights a fundamental fact in cancer care: timing is everything. Earlier diagnosis not only saves lives, but can also reduce the need for aggressive treatments, improve quality of life for patients, and ease pressure on healthcare systems.

A Path Forward

Closing the deadly cancer gap depends on progress in three critical areas: more research, better treatments and, crucially, earlier diagnosis. Improving how lung cancer is detected is one of the most powerful ways to shift outcomes.

At Cizzle Biotechnology, early detection sits at the heart of our mission. We are developing non-invasive, innovative blood-based diagnostic test designed to identify lung cancer at its earliest, most treatable stages, before symptoms appear and when intervention can make the greatest difference.

Changing Outcomes, Saving Lives

Closing the deadly cancer gap is not just about improving statistics. It is about people, patients, families and communities affected by devastating diagnoses each year. By focusing on early detection and continued innovation, lung cancer does not have to remain one of the least survivable cancers.

With the right tools and sustained commitment, we can help transform lung cancer from a disease detected too late into one caught early, giving more people the chance to survive and thrive.

One test. Earlier detection. More lives saved.

As Lung Cancer Awareness Month draws to a close, we’re taking a moment to reflect on a global movement that once again united researchers, clinicians, patients, and advocates throughout November. Each year brings fresh urgency and new breakthroughs and 2025 has been no exception.

The Global Challenge

The 2025 Lung Cancer Awareness Month theme is “This is Lung Cancer”, a campaign designed to challenge outdated perceptions and stigma by highlighting progress in diagnosis, treatment, and survivorship. It encourages people to seek help earlier and reinforces a critical truth: early diagnosis saves lives. When lung cancer is detected at an earlier stage, treatment options are broader, outcomes are significantly better, and patients have a far greater chance of long-term survival. The campaign also emphasises that lung cancer can affect anyone, regardless of smoking history.

Lung cancer remains the world’s most common cancer and its leading cause of cancer-related death, with nearly 2.5 million diagnoses and more than 1.8 million lives lost in 2022. These numbers reflect a hard fact: lung cancer is often detected too late. Symptoms rarely present in the early stages, leaving both patients and clinicians racing against time.

Yet, despite strong efforts from advocacy groups, uptake of lung cancer screening remains low among at-risk groups, and current national guidelines still exclude a significant portion of people who go on to develop the disease. A major study by Northwestern Medicine of nearly 1,000 lung cancer patients found that only 35% would have qualified for screening under the existing US Preventive Services Task Force criteria, leaving nearly two-thirds, disproportionately women and never-smokers, missed entirely.

This gap in eligibility is one of the reasons almost 80% of lung cancer cases are still diagnosed at advanced stages, where five-year survival drops to around 10%. As the Washington Post[1] recently highlighted, the growing population of never-smokers developing lung cancer remains ‘invisible’ to current screening guidelines, underscoring the need for more inclusive and accessible early-detection pathways.

This year’s global awareness message couldn’t be clearer: anyone can get lung cancer. Advocacy organisations around the world are continuing to dismantle outdated stigma and highlight a crucial reality, risk factors vary, cases among never-smokers are rising, and early detection must be accessible to all.

The Early Detection Revolution

In 2025, the field of oncology has seen transformative strides in early lung cancer detection, shifting from reliance on low-dose computed tomography (LDCT) scans alone toward integrated, personalised approaches that leverage biomarkers, artificial intelligence (AI), and non-invasive testing.

These approaches move beyond traditional imaging by looking for disease-specific signals in the blood, enabling earlier intervention, with fewer false positives and greater patient convenience.

Cizzle Biotechnology Holdings PLC’s Year of Milestones

For Cizzle Biotechnology, this has been a defining year in our mission to transform lung cancer detection through our proprietary CIZ1B biomarker blood test, which has demonstrated 95% sensitivity for early-stage disease.

This year, we delivered several major steps forward:

• North American Expansion – Having completed our exclusive licensing agreement with Cizzle Bio Inc. for the USA and Canada, our licensing partners have signed their first contracts with commercial clinical laboratories to launch our biomarker test following CLIA certification, opening the door to one of the world’s largest healthcare markets.
• UK Healthcare Engagement – We signed a Letter of Intent with a major UK laboratory provider serving the National Health Service, which may lead to an exclusive UK partnership and co-branded rollout across NHS and private markets in the UK. This underscores our commitment to making early lung cancer detection accessible nationally.
• Clinical Validation at Leading Centres – Our selection by the Moffitt Cancer Center in Florida marked a pivotal milestone, the first major clinical evaluation of the CIZ1B biomarker in patients with suspicious lung nodules.
• Advancing the Science – We continue to collaborate with the University of York, driving innovation and creating new IP for the CIZ1B biomarker.

Looking Ahead

With scientific innovation, clinical evaluation, and commercial partnerships aligning, 2026 is set to be a transformative year for blood-based lung cancer screening. Using biomarker-driven tests like ours offer a powerful complementary pathway to LDCT scanning helping provide earlier, more accurate detection.

As this awareness month closes, we’re reminded that progress is born from persistence, partnership, and purpose. The breakthroughs emerging today offer hope for tomorrow’s patients, and Cizzle remains committed to leading that change.

One test. Earlier detection. More lives saved.

[1] https://www.washingtonpost.com/health/2025/11/24/lung-cancer-screening-guidelines/