Validated Biomarker Blood Test Detects Early Lung Cancer and Supports Risk Assessment

Lung cancer is often diagnosed at advanced stages because symptoms typically appear late, while participation in low-dose computed tomography (LDCT) screening remains low. Imaging can also produce false-positive findings that lead to unnecessary follow-up, underscoring the need for adjunctive, minimally invasive tools to refine risk assessment. A newly validated blood test now detects a protein variant associated with early-stage lung cancer and is intended to complement LDCT in supporting clinical decision-making.

Cizzle Bio’s CIZ1B is a biomarker blood test that has completed laboratory validation at OmniHealth Diagnostics, a CLIA-certified, COLA-accredited clinical laboratory in Dallas and part of the Katharos Health family of laboratories. With validation complete, the company is finalizing launch-readiness activities ahead of the test’s expected near-term availability to U.S. healthcare providers. The validation confirms that the assay is ready for use within a U.S. clinical laboratory environment.

Image: About 14.2 million Americans are eligible for annual lung cancer screening, but uptake remains low and LDCT false positives persist; CIZ1B may improve risk stratification and reduce uncertainty (Image Credit: Adobe Stock)

The CIZ1B biomarker 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 LDCT screening and other standard diagnostic approaches. The test is positioned to help clinicians assess cancer risk, clarify indeterminate findings, and support clinical decision-making.

Offered as a laboratory-developed test (LDT), CIZ1B requires each CLIA-certified laboratory that performs the assay to complete its own validation to verify analytical performance and ensure compliance with quality standards. Completion of the process at OmniHealth Diagnostics establishes a foundation for broader access as additional CLIA-certified laboratory partners complete validation.

Prior studies reported 95% sensitivity for stage I lung cancer detection and a 96% negative predictive value, supporting its potential role as an adjunctive tool for early detection. The assay builds on more than three decades of research at the University of York and is being evaluated in clinical studies with leading National Cancer Institute–designated cancer centers, including Moffitt Cancer Center.

Lung cancer remains the leading cause of cancer-related deaths globally, with more than 229,000 new U.S. cases expected in 2026. Later-stage diagnosis can reduce five-year survival rates to approximately 10%, whereas early detection can raise five-year survival to about 65%. Approximately 14.2 million Americans are eligible for annual screening, yet uptake remains low and LDCT can produce false positives; the CIZ1B test may enhance risk stratification and reduce diagnostic uncertainty.

“The laboratory validation of CIZ1B marks an important milestone in our mission to expand access to innovative tools for early cancer detection. Lung cancer outcomes are closely tied to how early the disease is detected. By advancing a blood-based biomarker test, we aim to close critical gaps in early detection and help patients and their healthcare providers make more informed decisions about next steps in care,” said Bill Behnke, founder and chief executive officer of Cizzle Bio.

“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,” said Steve Kamalic, chief executive officer of OmniHealth Diagnostics.

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