DALLAS, June 16, 2026 /PRNewswire/ — Cizzle Bio, Inc., a Texas-based biotechnology company advancing biomarker blood tests for early detection of lung and gastric cancers, today announced the laboratory validation of its proprietary CIZ1B biomarker blood test for early lung cancer at OmniHealth Diagnostics, a CLIA-certified, COLA-accredited clinical laboratory based in Dallas and a member of the Katharos Health family of laboratories. With laboratory validation complete, Cizzle Bio is now finalizing launch readiness activities in preparation for the test’s near-term availability to U.S. healthcare providers.

The CIZ1B biomarker test is a novel, ELISA-based immunoassay that detects a protein variant associated with early-stage lung cancer using less than a tablespoon of blood. Designed to complement low-dose CT (LDCT) screening and other standard diagnostic approaches, the test can help clinicians assess cancer risk, clarify indeterminate findings and support clinical decision-making.

Because CIZ1B is offered as a laboratory-developed test (LDT), each CLIA-certified laboratory that performs the assay must complete its own validation process to verify analytical performance and ensure compliance with rigorous quality standards. Completion of the validation process at OmniHealth Diagnostics confirms the test’s readiness for use within a U.S. clinical laboratory environment and establishes a foundation for broader access as Cizzle Bio expands validation efforts with additional CLIA-certified laboratory partners.

Prior studies of the assay reported 95% sensitivity for stage I lung cancer detection and a 96% negative predictive value (NPV), supporting its potential role as an adjunctive tool for early detection.

“The laboratory validation of CIZ1B marks an important milestone in our mission to expand access to innovative tools for early cancer detection,” said Bill Behnke, founder and chief executive officer of Cizzle Bio. “Lung cancer outcomes are closely tied to how early the disease is detected. By advancing a blood-based biomarker test, we aim to close critical gaps in early detection and help patients and their healthcare providers make more informed decisions about next steps in care.”

Lung cancer remains the leading cause of cancer-related deaths in the United States and worldwide, with more than 229,000 new cases expected to be diagnosed in the United States in 2026, according to the American Cancer Society. Because symptoms often do not appear until the disease has advanced, lung cancer is frequently diagnosed at later stages, when five-year survival rates can fall to approximately 10%. By contrast, five-year survival rates approach 65% when lung cancer is detected early, according to the American Lung Association.

While approximately 14.2 million Americans are eligible for annual lung cancer screening under current U.S. Preventive Services Task Force guidelines, screening uptake remains low, and LDCT can produce false positives that lead to unnecessary follow-up procedures. The CIZ1B biomarker test may enhance risk stratification and reduce diagnostic uncertainty.

“We are committed to bringing high-quality diagnostic solutions into clinical practice,” said Steve Kamalic, chief executive officer of OmniHealth Diagnostics. “Guided by a dedication to quality, scientific rigor, and clinical excellence, we are proud to partner with Cizzle Bio to help expand access to a promising new biomarker tool that may support earlier identification of lung cancer.”

Built on more than three decades of research led by Professor Dawn Coverley, Ph.D., at the University of York, CIZ1B is being further evaluated in clinical studies with leading NCI-designated cancer centers, including Moffitt Cancer Center.

About Cizzle Bio, Inc.

Cizzle Bio, Inc. is a Texas-based biotechnology company dedicated to revolutionizing cancer diagnostics by advancing biomarker-based blood tests, starting with early detection of lung and gastric cancers. The company’s goal is to empower patients, equip clinicians, and improve outcomes through innovation, compassion, and life-saving solutions. Cizzle Bio holds exclusive licensing rights for its groundbreaking CIZ1B biomarker test in the United States, Canada, and the Caribbean and a worldwide exclusive license for its DEX-G2 biomarker gastric cancer test. The company is commercializing both tests for U.S. clinical environments.
www.cizzlebio.com

About OmniHealth Diagnostics

A member of the Katharos Health family of laboratories, OmniHealth Diagnostics is a Richardson, Texas-based clinical diagnostics laboratory offering a comprehensive portfolio of testing services, including genetic testing, molecular diagnostics, clinical laboratory testing, toxicology, and pharmacogenomics. Operating as a CLIA-certified, COLA-accredited clinical laboratory, OmniHealth is committed to delivering precise, accurate, and reliable results through rigorous quality standards and advanced laboratory practices.
www.omnihealthdx.com

Media Contact:

Yolanda Heiberger
yolanda@cizzlebio.com

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SOURCE Cizzle Bio