CIZ1B Biomarker Test for Early Lung Cancer Detection

Coming Soon to U.S. Clinical Settings

A Novel Blood-Based Immunoassay Supporting Earlier Clinical Decisions

The CIZ1B biomarker test is a breakthrough, minimally invasive ELISA-based immunoassay designed to detect early-stage lung cancer through a simple blood draw. Developed from more than 30 years of research into the CIZ1 gene and its role in cell cycle regulation, CIZ1B represents a promising new tool to aid in early detection, risk stratification, and surveillance in high-risk patients.

Test Performance

0%

Sensitivity for Stage I Lung Cancer

0%

Negative Predictive Value (NPV)

Analytical validation based on UK population studies

Preliminary U.S. clinical validation data forthcoming from ongoing clinical studies at NCI-designated cancer centers, including Moffitt Cancer Center and UT Health San Antonio MD Anderson Cancer Center

CIZ1B may be used to support clinical decision-making in the following scenarios:

Potential Clinical Use Cases

  • Screening-eligible patients who are unable or unwilling to undergo LDCT

  • Adjunctive test to assess malignancy risk in patients with indeterminate pulmonary nodules

  • Longitudinal surveillance in patients with a history of lung cancer or familial risk

  • High-risk individuals with occupational/environmental exposures (e.g., radon, asbestos, chronic wildfire smoke)

  • Patients with chronic lung conditions such as COPD or pulmonary fibrosis

When the Test is Positive—A Sample Diagnostic Pathway

1

CIZ1B+ Positive Result

2

LDCT or diagnostic CT

3

Pulmonary nodule risk assessment

4

Tissue biopsy if indicated

5

Treatment discussion* (surgery, radiation, or systemic therapy)

*Note: Clinical decision-making remains at the discretion of the treating provider. CIZ1B is designed to complement—not replace—standard-of-care protocols.

Study abstract by healthcare economist Jennifer Hinkel, M.Sc., published in conjunction with the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, showed integrating the CIZ1B biomarker blood test into Medicare lung cancer screening could save $518 million annually.

Ordering and Logistics for Clinicians

When available, licensed U.S. healthcare providers can order the CIZ1B test via a secure online portal on this clinician page.

  • Test type – ELISA-based immunoassay (LDT – Laboratory Developed Test)

  • Ordering – Available to licensed U.S. healthcare providers via secure online portal

  • Processing Conducted by CLIA-certified, CAP-accredited partner laboratories

  • Turnaround time – 72 hours from receipt of sample

  • Billing - Initially private pay; CPT application to follow

  • Support – Full-service customer support team with access to Chief Medical Officer for clinical questions

Stay Informed

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The CIZ1B biomarker test is a turning point in early detection. Help your patients take control of their health with earlier, evidence-based insight.