Cizzle Bio is advancing the commercial use of its CIZ1B biomarker blood test for lung cancer, providing a minimally invasive source of additional information for clinicians assessing patients at risk of the disease.
The company’s latest educational material explains how a blood-based biomarker test can complement existing approaches when a pulmonary nodule has been identified. Cizzle Bio stresses that the CIZ1B test is not intended to diagnose lung cancer on its own or replace low-dose CT scans, other imaging, biopsy or specialist assessment. Instead, it is designed to provide another data point alongside a patient’s medical history, symptoms, risk factors and imaging results.
The CIZ1B test measures a protein variant associated with lung cancer using an ELISA-based immunoassay. The test requires a simple blood sample, making it considerably less invasive than diagnostic procedures involving tissue sampling. Cizzle Bio is targeting applications where clinicians need additional information to assess the likelihood that a pulmonary nodule is malignant.
Pulmonary nodules are not automatically cancerous. Doctors must consider factors including the size and appearance of a nodule, changes over time, smoking history, family history, symptoms and occupational or environmental exposure. Cizzle Bio says CIZ1B can provide additional biomarker information within that wider assessment rather than being used as a standalone diagnostic.
Recent peer-reviewed research has added clinical evidence to the development programme. A study published in the Journal of Applied Laboratory Medicine evaluated 143 plasma samples from patients with and without lung cancer. In the early-stage cohort, CIZ1B demonstrated 94% sensitivity for Stage I and Stage II lung cancer and a 97% negative predictive value. The research also identified indeterminate pulmonary nodules as a potential application for the test.
Cizzle Bio has already moved beyond development towards commercial deployment in the US. The CIZ1B test is available through licensed healthcare providers in the Dallas-Fort Worth and San Antonio metropolitan areas, with the company working through a CLIA-certified laboratory partner.
Cizzle Biotechnology Holdings plc (LON:CIZ) is a pioneering cancer diagnostics company, originally a spin-out from the University of York, and now listed on the London Stock Exchange.
