CIZ1B Biomarker Test for Early Lung Cancer Detection
Coming Soon to U.S. Healthcare Providers
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
Sensitivity for Stage I Lung Cancer
Negative Predictive Value (NPV)
Based on UK Analytical Validation Studies.
Preliminary U.S. clinical validation data forthcoming from ongoing clinical studies at NCI-designated cancer centers, including Moffitt Cancer Center and Mays Cancer Center/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
5
Treatment discussion* (surgery, radiation, or systemic therapy)
4
Tissue biopsy if indicated
*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
Results - Delivered via secure, online portal with email notification.
Billing - Initially private pay; CPT application to follow
Support - Full-service customer support team with access to Chief Medical Officer and Clinical Advisor 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.