Cizzle Biotechnology Holdings plc (LON:CIZ), the UK based diagnostics developer of early cancer tests, has announced the successful laboratory accreditation of its proprietary test for the CIZ1B biomarker which is highly associated with early-stage lung cancer. Working closely with the Company’s North American licensing partner Cizzle Bio Inc, the test is now approved for use under Clinical Laboratory Improvement Amendments accreditation at OmniHealth Diagnostics, a CLIA-certified, COLA-accredited clinical laboratory based in Dallas, Texas.
CLIA approval is regulated by the Centers for Medicare & Medicaid Services and signifies that a laboratory’s testing processes and assays meet US federal standards for timely clinical accuracy, reliability, and patient safety and will now enable the test to be made available to licensed U.S. healthcare providers. CLIA compliance is also mandatory for a laboratory to receive Medicare and Medicaid reimbursements.
Highlights
· CIZ1B biomarker test successfully accredited for clinical use in the U.S. under CLIA
· Provides a regulated U.S. laboratory route to market for the Company’s early lung cancer blood test
· CLIA accreditation meets US federal standards for timely, accurate and reliable clinical testing and patient safety
· Enables licensed U.S. healthcare providers to order the test signifying commercial launch
· Establishes foundation for revenue generation, reimbursement pathways and wider US adoption
The Unmet Clinical Need
Lung cancer remains the leading cause of cancer-related deaths in the United States and worldwide, accounting for more deaths annually than breast, prostate, and colorectal cancers combined, according to the American Cancer Society. In the United States alone, more than 234,000 new cases are diagnosed each year and globally this number of rises to over 2.2 million people.
Because symptoms often do not appear until the disease is advanced, lung cancer is frequently diagnosed at later stages, when five-year survival rates can fall to approximately 10%. In contrast, detection at Stage I dramatically improves survival to as high as 90%, underscoring the urgent need for effective early-detection tools that complement existing screening pathways. The availability of validated, minimally invasive diagnostic tools is therefore, particularly important as lung cancer screening guidelines expand. The U.S. Preventive Services Task Force estimates that approximately 14.2 million Americans are now eligible for annual lung cancer screening. However, screening uptake remains low, and low-dose CT (“LDCT”) can produce false positives that lead to unnecessary follow-up procedures. Blood-based biomarkers such as CIZ1B have the potential to enhance risk stratification, reduce diagnostic uncertainty, and improve the efficiency of care.
The CIZ1B biomarker test is a novel, ELISA-based immunoassay that detects a specific protein variant associated with early-stage lung cancer through a simple blood draw. The test is designed to complement LDCT screening and other standard-of-care diagnostic approaches, helping clinicians assess cancer risk, clarify indeterminate findings, and make more informed clinical decisions.
Unlike multi-cancer early detection (MCED) tests that rely on detecting circulating tumor DNA (ctDNA) bearing mutation or methylation signals, CIZ1B is designed to detect a stable tumor-associated protein biomarker linked to lung cancer at its earliest stage. This distinct biomarker approach offers important advantages in identifying disease when intervention has the greatest potential to improve outcomes. CIZ1B is offered as a laboratory developed test (LDT) and is performed exclusively within CLIA-certified laboratory environments, ensuring rigorous quality oversight, analytical control, and compliance with applicable regulatory standards.
The validation at OmniHealth confirms the test’s analytical performance and operational readiness within a U.S. clinical laboratory environment, supporting scalability, reproducibility, and integration into routine diagnostic workflows. This provides an accredited base to roll the test out across the USA and establishes a strong foundation for growth in other global and home markets.
Translating Decades of Research into Clinical Practice
The CIZ1B biomarker test is built on foundational research into cancer origins, and the CIZ1 protein’s role in epigenetic stability, led by Professor Dawn Coverley at the University of York. Her work led to the discovery of the CIZ1B protein variant and its strong association with lung cancer, and the development of molecular tools that can measure CIZ1B with high sensitivity in patients with early-stage lung cancer. With CLIA accreditation, clinicians and patients will now have access to a scalable test that can help with the detection of lung cancer in its early stages and improve a patient’s chance of survival.
Achieving CLIA accreditation is necessarily a complex and challenging task and was made possible through working closely with Cizzle’s North American licencing partner, BIO, and it’s clinical laboratory partner OmniHealth, bringing together the necessary research, development, regulatory, clinical and commercial expertise to deliver a vision to transform lung cancer survival through accurate, low cost, non-invasive early detection at scale.
As part of the Company’ global licensing strategy, there has been a first focus on the world’s largest market in North America to launch its first commercial test. The goal is now to continue to work with the Company’s partners to deliver early adoption and scale up. Having established a regulatory approved route to market in the USA, the Company is now also exploring new commercial relationships in the UK, elsewhere in Europe and Asia. This strategy aims to continue to deliver shareholder value through licensing-based royalty payments and potential benefits arising from equity participation in the partner companies where possible.
Commenting, Professor Dawn Coverley, Founder and CSO 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.”
Commenting, 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 CIZ1B 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. As with any major challenge, it requires expert and determined collaboration to achieve significant breakthroughs in the fight against cancer. The outstanding efforts from our team at the University of York along with BIO and the clinical laboratory team at Omni are testament to making this potentially lifesaving test a reality.”
Commenting, Bill Behnke, Founder and CEO of Cizzle Bio, said:
“Validating CIZ1B in a U.S. CLIA-certified, COLA-accredited laboratory is a pivotal milestone as we move toward broader clinical availability. Lung cancer outcomes are closely tied to how early the disease is detected. By advancing a blood-based biomarker test with strong performance, we aim to close critical gaps in early detection, help patients get answers sooner and improve lives.”
Commenting, Steve Kamalic, Chief Executive Officer of OmniHealth Diagnostics said:
“We are committed to bringing high-quality diagnostic solutions into clinical practice. Guided by a dedication to quality, scientific rigor, and clinical excellence, we are proud to partner with Cizzle Bio to help expand access to a promising new biomarker tool that may support earlier identification of lung cancer.”
