Cizzle Biotechnology announced further progress on the commercial roll out of the Company's CIZ1B biomarker test in North America by its exclusive Licensing partner Cizzle Bio Inc. BIO is now completing validation of the test with its new clinical diagnostics laboratory group, Omni Health Diagnostics ("Omni"), as part of a national expansion strategy based on Omni's active laboratory acquisitions and partnerships programme to provide testing capability in Texas, New York, California, South Carolina, Tennessee and Florida which will provide nationwide testing coverage. It is expected that BIO will add further clinical laboratory partners as required to be able to meet anticipated market demand across North America when the test completes Clinical Laboratory Improvement Amendments ("CLIA") accreditation as a Laboratory Developed Test ("LDT"). Omni intends to enable a multiple site testing capability from COLA or CAP and CLIA accredited laboratories to meet anticipated demand following the planned launch of the test in the near term.
The Company has received further advance payments from BIO as part of the revised royalty payment schedule. The Company has been working closely with its exclusive licensing partner BIO to market its proprietaryCIZ1B biomarker test to help detect early-stage lung cancer, throughout the USA, Canada and the Caribbean as a LDT in CLIA accredited laboratories. As announced on 18 August 2025, BIO has initiated a US national strategy for accreditation and market launch across multiple sites as part of a wider co-ordinated and comprehensive campaign to roll out the CIZ1B biomarker testing in North America to help detect early-stage cancer.
The Company can now announce that BIO has teamed with Omni a CLIA-certified diagnostic laboratory headquartered in Richardson, Texas. It specialises in a comprehensive range of testing services, including pharmacogenomics, molecular diagnostics, clinical testing, genetic testing, and diagnostics for medical fields such as cardiology, oncology, neurology, and infectious diseases. Omni focuses on delivering precise, accurate, and reliable results to support healthcare providers and patients and has an active expansion programme to acquire or partner with other accredited laboratories throughout the USA including New York, California, South Korea, Tennessee and Florida to enable a nationwide testing capability.
While initially to be offered as a private pay for test, they intend to secure CPT (Current Procedural Terminology) codes to allow payment by Medicare and Medicaid. BIO and Omni will engage in a progressive marketing campaign, working closely with patient advocacy groups to enable easy patient engagement and so reduce premature cancer deaths and improve survival rates and quality of life for cancer patients. On 18 August 2025, the Company announced that it had received initial payments totaling USD 525,000 from its exclusive licensing agreement with BIO as part of a guaranteed payment schedule due to the Company totaling USD 2.4 million to be paid in full before the end of 2026.
These payments are advance payments from royalties of 10% on sales revenue in North America and the Caribbean. Omni has since made further payments as part of a revised regular payment that continues to support the Company's cash flow requirements.
