#United States #Dallas #Cizzle Bio #CIZ1B #OmniHealth

Cizzle Bio Validates CIZ1B Biomarker Blood Test for Lung Cancer

Cizzle Bio, Inc., a Texas-based biotechnology firm, has made a significant advancement in the field of cancer diagnostics. The company recently announced the successful laboratory validation of its proprietary CIZ1B biomarker blood test for early lung cancer detection at OmniHealth Diagnostics, a renowned clinical laboratory certified under CLIA and accredited by COLA, located in Dallas, Texas.

The CIZ1B test represents a pioneering approach to early lung cancer diagnosis. It operates on an ELISA-based immunoassay platform and requires just a small blood sample—less than a tablespoon—to identify a specific protein variant tied to early-stage lung cancer. This biomarker test is designed not only to enhance standard low-dose CT screening but also to assist healthcare providers in evaluating cancer risk and addressing ambiguous clinical findings effectively.

"The laboratory validation of CIZ1B marks a significant milestone in our mission to broaden access to groundbreaking cancer detection tools," commented Bill Behnke, the CEO of Cizzle Bio. This statement underscores the importance of early detection in improving survival outcomes for lung cancer patients, which is crucial given that lung cancer remains the leading cause of cancer-related deaths across the globe.

The successful validation indicates that the CIZ1B test is ready for integration into clinical laboratory environments across the U.S. This important milestone paves the way for a wider implementation of the test, with Cizzle Bio planning ongoing validation efforts in partnership with additional CLIA-certified laboratories.

Research has shown that the CIZ1B test boasts an impressive 95% sensitivity in detecting stage I lung cancer, complemented by a 96% negative predictive value. This capability supports its potential role as an important tool for early cancer detection. Its introduction comes at a crucial time, as the American Cancer Society projects over 229,000 new lung cancer cases to be diagnosed in the U.S. in 2026—making early and accurate detection more urgent than ever.

Currently, around 14.2 million Americans qualify for annual lung cancer screening based on the guidelines provided by the U.S. Preventive Services Task Force. However, the uptake for such screenings is notably low, partly due to the limitations of current screening methods, which may yield false-positive results, leading to unnecessary follow-ups. In this context, the CIZ1B biomarker test could significantly refine the risk stratification process, potentially reducing the uncertainties associated with lung cancer diagnostics.

Steve Kamalic, CEO of OmniHealth Diagnostics, expressed enthusiasm about the partnership with Cizzle Bio, stating, "We are dedicated to integrating superior diagnostic solutions into healthcare practice. By adhering to stringent quality standards and scientific rigor, we proudly join efforts with Cizzle Bio to expand access to this promising biomarker tool, aiming to enhance early identification of lung cancer."

The CIZ1B test is rooted in three decades of extensive research led by Professor Dawn Coverley, Ph.D., at the University of York. Further clinical studies involving this test are underway, being conducted with several leading NCI-designated cancer centers, including the distinguished Moffitt Cancer Center.

About Cizzle Bio, Inc.

Cizzle Bio is committed to transforming cancer diagnostics through the development of innovative biomarker-based blood tests, emphasizing early detection of both lung and gastric cancers. The company aspires to empower patients and equip healthcare providers with the tools necessary for informed clinical decisions. Cizzle Bio has exclusive licenses for its pioneering CIZ1B biomarker test in the U.S., Canada, and the Caribbean, and is in progress of commercializing these tests within clinical practices in the U.S.

About OmniHealth Diagnostics

As a member of the Katharos Health family of laboratories, OmniHealth Diagnostics, located in Richardson, Texas, offers a robust suite of diagnostic testing services, adhering to the highest quality assurance benchmarks, including CLIA certification and COLA accreditation. They are dedicated to delivering precise and reliable results across various medical testing fronts, including genetic evaluations and molecular diagnostics.

For more information, visit the official websites of Cizzle Bio and OmniHealth Diagnostics.