The Evidence Supporting CIZ1B: Peer-Reviewed Research on the Lung Cancer Biomarker Blood Test
2026 Peer-Reviewed Evidence
The CIZ1B Biomarker Blood Test for Lung Cancer is supported by peer-reviewed research published Aug. 19, 2026, in The Journal of Applied Laboratory Medicine. The study by Rose et al. evaluated the same ELISA-based CIZ1B assay that is commercially available to healthcare providers in Dallas-Fort Worth and San Antonio.
Researchers evaluated 143 plasma samples across three independent clinical sample sets from patients with and without lung cancer. In the cohort focused on early-stage disease, CIZ1B demonstrated 94% sensitivity and a 97% negative predictive value (NPV). All 18 patients with lung cancer in this cohort had stage I or stage II disease.
The 2026 study builds on earlier peer-reviewed research evaluating CIZ1B as a lung cancer biomarker, including the 2012 study by Higgins et al. published in Proceedings of the National Academy of Sciences and the 2017 study by Coverley et al. published in Clinical Biochemistry. Together, this body of work reflects the continued development of CIZ1B from biomarker discovery toward a scalable assay designed for clinical laboratory use.
CIZ1B is designed to complement LDCT, imaging findings, clinical risk factors and other diagnostic information by providing physicians with additional biomarker insight as part of a comprehensive clinical assessment.
The Evidence at a Glance
Key Findings From the 2026 Study
Evaluated 143 plasma samples across three independent clinical sample sets.
Used a scalable sandwich ELISA designed for clinical laboratory application.
Demonstrated 94% sensitivity in the early-stage cohort, correctly identifying 94% of patients with stage I or II lung cancer.
Demonstrated a 97% NPV in that cohort, meaning 97% of individuals with a non-elevated result did not have lung cancer within the study population.
Included 18 patients with lung cancer in the early-stage cohort, all with stage I or stage II disease.
Reported ROC AUC values of 0.82, 0.81 and 0.86 across the three sample sets.
These performance estimates were generated from defined research populations under specific study conditions and may not reflect performance in every clinical setting or patient population.
Designed for Clinical Laboratory Use
The study describes a scalable sandwich ELISA for measuring CIZ1B in small quantities of plasma. The assay uses a highly specific monoclonal antibody, CIZB54, developed to recognize the CIZ1B variant associated with lung cancer.
Importantly, the research advances CIZ1B beyond biomarker identification by demonstrating a laboratory platform designed to support practical clinical use.
The authors also identified sample collection and handling, known as pre-analytic variables, as important considerations in maintaining consistent laboratory measurements.
Potential Clinical Utility in the Lung Cancer Diagnostic Pathway
One important potential application for CIZ1B is the evaluation of indeterminate pulmonary nodules.
When imaging identifies a suspicious or unresolved lung nodule, physicians must determine whether a patient should undergo additional imaging, biopsy or another diagnostic procedure. CIZ1B is designed to provide additional biomarker information that can be considered alongside imaging, patient history, clinical risk factors and other findings when determining the appropriate next step.
This is particularly relevant because detecting lung cancer at an earlier stage can significantly expand treatment options and improve outcomes, while imaging can also identify benign abnormalities that require additional evaluation.
CIZ1B is therefore intended to support—not replace—established lung cancer screening and diagnostic pathways.
Building the Clinical Evidence
The 2026 peer-reviewed findings provide important evidence supporting the clinical development of CIZ1B, particularly its ability to detect the biomarker in patients with early-stage lung cancer.
Additional clinical validation is underway at NCI-designated cancer centers and academic medical centers, including a study at Moffitt Cancer Center evaluating CIZ1B in patients with identified lung nodules. Research is assessing the biomarker's potential to:
Help distinguish malignant from benign pulmonary nodules.
Support clinical decision-making for patients with indeterminate findings.
Evaluate recurrence risk following curative treatment.
Support surveillance for recurrence or second primary lung cancers.
These studies are designed to further define how CIZ1B may be incorporated into real-world clinical pathways.
How CIZ1B Is Intended to Be Used
CIZ1B is a laboratory-developed biomarker blood test performed in a CLIA-certified, COLA-accredited high-complexity laboratory.
The test is designed to provide physicians with additional information as part of a broader clinical assessment. It is not a standalone diagnostic or screening test and does not replace LDCT, imaging, biopsy or physician judgment.
An elevated CIZ1B result is not, by itself, a diagnosis of lung cancer, and a non-elevated result does not exclude the possibility of lung cancer. Results should be interpreted by a licensed healthcare provider together with the patient's complete clinical assessment.
Bringing CIZ1B Into Clinical Practice
Licensed healthcare providers in Dallas-Fort Worth and San Antonio can now access CIZ1B and begin the provider onboarding and ordering process.
Providers can also review the additional information on clinical use, ordering and available resources:
References
Rose SF, Pearson JF, Byrom L, Ainscough JFX, Coverley D. A Molecular Tool Set for Measurement of Lung Cancer-Associated Protein Biomarker CIZ1B-FibA in Human Plasma. The Journal of Applied Laboratory Medicine. 2026. doi:10.1093/jalm/jfag124
