CIZ1B Biomarker Test for Early Lung Cancer Detection
Now Available in the Dallas-Fort Worth and San Antonio Metropolitan Areas
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 ¹
Negative Predictive Value (NPV) ¹
Based on UK Analytical Validation Study.
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
Potential Clinical Use Cases
CIZ1B may be used to support clinical decision-making in the following scenarios:
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. ²
Ordering and Logistics for Clinicians
To begin ordering the CIZ1B test, licensed U.S. healthcare providers must first complete OmniHealth Diagnostics’ new account/intake process.
How to Order the CIZ1B Biomarker Blood Test for Lung Cancer
1
Start account onboarding with our CLIA-certified laboratory partner, OmniHealth Diagnostics.
Use the link below to begin OmniHealth Diagnostics' new account/intake process.
Complete and submit the required intake information.
Provide the requested practice and provider details to begin account setup.
2
Receive portal access and onboarding invitation.
You will receive a welcome email from the OmniHealth Diagnostics customer service team within 24-48 hours with instructions for registering on the laboratory portal and an invitation to schedule an onboarding phone call with a member of the customer service team.
3
Complete the OmniHealth onboarding session.
With 48-72 hours, a live onboarding call with OmniHealth Diagnostics will review portal access, sample collection, shipping logistics, and expected turnaround times.
4
Place CIZ1B orders through the portal.
Once onboarding is complete, you can submit CIZ1B test orders and receive results through the secure online portal.
5
Begin CIZ1B Ordering Setup
Once the account is established, OmniHealth will provide portal
access for placing orders and receiving results.
Physician Onboarding Video
This brief video explains the OmniHealth onboarding process for portal access and CIZ1B test ordering.
Clinician Support
For questions about clinical use of the CIZ1B Biomarker Blood Test for Lung Cancer, clinicians may contact the Cizzle Bio Medical Affairs team at clinicians@cizzlebio.com.
References
-
Coverley D, Higgins G, West D, et al. A quantitative immunoassay for the lung-cancer biomarker CIZ1b in patient plasma. Clin Biochem. 2017;50(6):336-343.
-
Hinkel, J., Kavade, R., & Joshi, M. (2025, June). Modeling the economic impact of a CIZ1B biomarker blood test for lung cancer screening in high-risk populations [Abstract]. In Proceedings of the American Society of Clinical Oncology Annual Meeting. https://doi.org/10.1200/JCO.2025.43.16_suppl.e15091