Research presented at the Next Generation Dx Summit highlights the blood test’s sensitivity and its potential role in managing indeterminate lung nodules.
Cizzle Bio Inc presented clinical updates for its CIZ1B biomarker blood test at the 18th Annual Next Generation Dx Summit, highlighting its performance in detecting early-stage lung cancer. The presentation examined the role of the biomarker in patient management and provided an overview of an ongoing clinical study at Moffitt Cancer Center.
Lary A Robinson, director of the Lung Cancer Early Detection (LEAD) Center at Moffitt Cancer Center, discussed the clinical challenges associated with the 1.6 million lung nodules identified annually in the US. Current obstacles include low participation in low-dose CT (LDCT) screening and uncertainty regarding indeterminate pulmonary nodules, according to the company.
“A reliable blood test could help assess indeterminate lung nodules and reduce unnecessary invasive procedures,” says Robinson, director of the Lung Cancer Early Detection (LEAD) Center at Moffitt Cancer Center, in a release. Robinson also noted that blood-based biomarkers may provide information for monitoring patients after treatment.
Assay Performance and Clinical Evaluation
The CIZ1B biomarker is associated with early-stage lung cancer and was developed from research at the University of York. A study published in The Journal of Applied Laboratory Medicine evaluating the scalable enzyme-linked immunosorbent assay (ELISA) reported a sensitivity of approximately 94% and a negative predictive value of 97%, according to Cizzle Bio.
The assay is currently being evaluated at Moffitt Cancer Center in patients with identified lung nodules. The study is assessing the potential of the test to distinguish malignant from benign nodules, stratify recurrence risk after curative treatment, and support surveillance for second primary lung cancers or recurrence. Researchers are comparing results from blood collected at initial evaluation with clinical diagnoses, while also studying serial testing during follow-up.
“Dr Robinson’s presentation provided an important clinical perspective on the challenges physicians face in detecting lung cancer earlier and the research needed to determine how biomarkers such as CIZ1B may complement existing diagnostic approaches,” says Bill Behnke, CEO of Cizzle Bio, in a release.
Commercial Availability
Cizzle Bio launched the CIZ1B Biomarker Blood Test for licensed healthcare providers in July 2026. The initial phase of the rollout includes the Dallas-Fort Worth and San Antonio markets, with plans for a national strategy. The company holds exclusive licensing rights for the test in the US, Canada, and the Caribbean.
The Moffitt study is intended to help build the clinical evidence needed to understand where the biomarker may provide meaningful information in the lung cancer care pathway, says Behnke, CEO of Cizzle Bio, in a release.
