Cizzle Bio has announced laboratory validation of its CIZ1B biomarker blood test for early lung cancer at OmniHealth Diagnostics, a CLIA-certified and COLA-accredited clinical laboratory in Dallas.

With validation completed, the company is finalising launch readiness activities for the test’s near-term availability to U.S. healthcare providers. The test is being developed as a laboratory-developed test for clinical laboratory use.

This is relevant because lung cancer remains difficult to detect early. Symptoms often appear only after disease progression, and late-stage diagnosis is linked to poorer outcomes. Cizzle Bio cited more than 229,000 new lung cancer cases expected in the United States in 2026.

The CIZ1B test is an ELISA-based immunoassay that detects a protein variant associated with early-stage lung cancer using less than a tablespoon of blood. It is designed to complement low-dose CT screening and other standard diagnostic approaches, rather than replace them.

Prior studies of the assay reported 95 per cent sensitivity for stage I lung cancer detection and 96 per cent negative predictive value. The company said the test may help clinicians assess cancer risk, clarify indeterminate findings and support follow-up decision-making.

The validation at OmniHealth Diagnostics is important because each CLIA-certified laboratory performing an LDT must complete its own validation process to confirm analytical performance and quality compliance. This gives Cizzle Bio a foundation for broader access as it expands validation with additional CLIA-certified laboratory partners.

The target users include healthcare providers managing patients eligible for lung cancer screening, as well as clinicians evaluating uncertain findings from low-dose CT. While around 14.2 million Americans are eligible for annual screening under current U.S. guidelines, uptake remains low and false positives remain a challenge.