Cizzle Biotechnology Holdings (LSE:CIZ), the UK-based developer of early cancer diagnostic tests, said its CIZ1B biomarker test has been accredited for clinical use in the US under the Clinical Laboratory Improvement Amendments (CLIA), the country's framework for approving diagnostic laboratories.
The test, which detects a biomarker strongly associated with early-stage lung cancer, will be delivered through OmniHealth Diagnostics, a CLIA-certified, COLA-accredited laboratory in Dallas, Texas.
Cizzle's North American licensing partner, Cizzle Bio (BIO), plans to scale deployment across additional clinical laboratory sites in New York, California, South Carolina, Tennessee and Florida, aiming for nationwide US coverage.
Aggregate guaranteed minimum royalty receipts under the BIO agreement have risen to approximately $5.9 million, reflecting the partner's continued commitment to commercialising the technology in North America.
The company also secured patents covering its core CIZ1B measurement methods in both the US and Canada during the six months to 30 June, reinforcing intellectual property protection across its two most important North American markets.
"The first half of 2026 represents probably the most important period in Cizzle's development since the company was founded," said Allan Syms, Executive Chairman, adding that CLIA accreditation is "a major validation of both the science underpinning our technology and the significant work undertaken alongside our licensing partner BIO."
The board is now pursuing further royalty-bearing partnerships in the UK, Europe and Asia-Pacific, which it expects to carry low distribution and supply costs for Cizzle.
