UK diagnostics developer signs with multi-site laboratory group to scale commercial launch of early-stage lung cancer biomarker test across the United States.
Cizzle Biotechnology Holdings has entered into an agreement with a multi-site clinical diagnostics laboratory group to expand availability of its CIZ1B biomarker test for early-stage lung cancer detection throughout the US market.
The UK-based diagnostics developer announced that its North American licensing partner, Cizzle Bio Inc, has moved beyond its initial pathfinder laboratory arrangement to partner with a larger, COLA and CLIA-accredited laboratory network. The strategic shift aims to enable wider commercial distribution of the CIZ1B test as a Laboratory Developed Test in CLIA-accredited facilities.
The partnership expansion follows successful validation work completed by iGenomeDX, which served as the pathfinder clinical laboratory for establishing operating and quality systems. Based on that progress, Cizzle Bio has realigned its market launch strategy to work with the multi-site laboratory group for broader geographic coverage and operational scale.
Accelerated Payment Schedule
Alongside the laboratory partnership expansion, Cizzle Biotechnology has revised its advance royalty payment schedule with Cizzle Bio. The companies have agreed to accelerate the remaining $1.875 million in guaranteed advance royalties, with full payment now scheduled by the end of 2026 rather than the previously agreed April 2027 deadline.
Cizzle Bio made an early payment of $125,000 in July 2025, bringing total receipts to date to $525,000 of the guaranteed $2.4 million in advance payments. The revised payment schedule reflects both companies’ cash flow requirements during the commercial launch period.
The original licensing agreement, announced in October 2024, granted Cizzle Bio exclusive rights to market the CIZ1B biomarker test throughout the US and Canada. The territory was later expanded in December 2024 to include 14 sovereign states of the Caribbean and the Cayman Islands.
Commercial Strategy Evolution
The move to a multi-site laboratory partner represents a strategic evolution from Cizzle Bio’s original plan to complete individual contracts with multiple laboratory partners following the pathfinder phase. The new approach is designed to support coordinated market rollout and meet anticipated commercial demand for the lung cancer screening test.
“Following the progress made by their pathfinder clinical laboratory, BIO’s strategy has developed to more appropriately reflect the large market opportunity they are seeing for the Company’s CIZ1B biomarker test in North America,” says Allan Syms, executive chairman of Cizzle Biotechnology, in a release. “…This new agreement with a significantly larger multi-site clinical laboratory demonstrates how BIO intends to scale its operations throughout the USA.”
The multi-site laboratory arrangement is intended to ensure operational consistency and cost-effective scalability for the CIZ1B assay while maintaining expected reproducibility and sensitivity standards across testing locations.
The CIZ1B biomarker test is designed to help detect early-stage lung cancer, with the goal of reducing premature cancer deaths and improving survival rates for patients through earlier intervention.
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