Research supports potential use of CIZ1B to help physicians assess indeterminate pulmonary nodules and guide diagnostic follow-up

SAN ANTONIO, Sept. 1, 2026 /PRNewswire/ — Cizzle Bio Inc., a biotechnology company advancing biomarker blood tests for early cancer detection, has announced the publication of new peer-reviewed research supporting the clinical utility of the CIZ1B biomarker for early lung cancer detection.

Published Aug. 19 in The Journal of Applied Laboratory Medicine, the study, “A Molecular Tool Set for Measurement of Lung Cancer-Associated Protein Biomarker CIZ1B-FibA in Human Plasma,” evaluated CIZ1B-FibA in blood plasma from patients with and without lung cancer. Led by Professor Dawn Coverley of the University of York, the study evaluated the same ELISA-based CIZ1B biomarker assay recently launched commercially by Cizzle Bio for healthcare providers in Dallas-Fort Worth and San Antonio, adding peer-reviewed evidence supporting the scientific and clinical foundation of the commercial test.

The study evaluated 143 plasma samples across three independent clinical samples sets from patients with and without lung cancer. In the cohort focused on early-stage disease, CIZ1B demonstrated 94% sensitivity, correctly identifying 94% of patients with stage I or stage II lung cancer, and a 97% negative predictive value (NPV), indicating that 97% of individuals who received a negative result in this study cohort did not have lung cancer. All 18 patients with lung cancer in this cohort had stage I or stage II disease, underscoring the potential of CIZ1B in helping physicians assess lung cancer at earlier, potentially more treatable stages.

“This publication adds important peer-reviewed evidence supporting CIZ1B and its potential to provide physicians with additional information when evaluating patients for lung cancer,” said Bill Behnke, CEO of Cizzle Bio. “One of the most compelling applications is the assessment of indeterminate pulmonary nodules, where imaging alone may not provide a clear answer about whether a nodule is cancerous.”

The study identifies indeterminate lung nodules as a potential clinical use for the CIZ1B test, where it could help physicians assess the likelihood of lung cancer and guide decisions about imaging, biopsy or other diagnostic follow-up.

Earlier detection remains a challenge in lung cancer care. The study notes that only about 20% of patients are diagnosed at stage I, when five-year survival ranges from 68% to 92%, compared with less than 10% at stage IV. While low-dose CT screening reduces mortality, it can also lead to false-positive findings, repeat imaging and invasive follow-up procedures.

The research further supports the clinical utility of the CIZ1B test and builds on previous peer-reviewed studies of the biomarker. Clinical validation studies are underway at Moffitt Cancer Center and other academic medical and National Cancer Institute-designated cancer centers.

Read the full study: https://go.cizzlebio.com/okTFGM

About Cizzle Bio Inc.

Cizzle Bio is a Texas-based biotechnology company dedicated to revolutionizing cancer diagnostics by advancing biomarker-based blood tests, starting with early detection of lung cancer. The company’s goal is to empower patients, equip clinicians and improve outcomes through innovative, compassionate and life-saving solutions. Cizzle Bio holds exclusive licensing rights for its groundbreaking CIZ1B Biomarker Blood Test for Lung Cancer in the United States, Canada and the Caribbean. The company is commercializing the test for U.S. clinical environments. Learn more at CizzleBio.com

Media Contact:

Yolanda Heiberger

yolanda@cizzlebio.com

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SOURCE Cizzle Bio