The CIZ1B biomarker assay is designed to complement LDCT screening by helping assess lung cancer risk and clarify indeterminate findings.
Cizzle Bio announced the laboratory validation of its CIZ1B biomarker blood test for early lung cancer at OmniHealth Diagnostics, a clinical laboratory based in Dallas. With the validation process finished, Cizzle Bio is preparing for the test to become available to US healthcare providers.
The test is an enzyme-linked immunosorbent assay that identifies a protein variant associated with early-stage lung cancer. It requires less than a tablespoon of blood and is intended to be used alongside low-dose computed tomography (LDCT) screening and other standard diagnostic methods to help clinicians assess cancer risk and clarify indeterminate findings.
As a laboratory-developed test, the assay requires validation by each facility certified under the Clinical Laboratory Improvement Amendments. The completion of this process at OmniHealth Diagnostics, a member of the Katharos Health family of laboratories that is also accredited by the Commission on Office Laboratory Accreditation, confirms the test is ready for clinical use in the US.
“The laboratory validation of CIZ1B marks an important milestone in our mission to expand access to innovative tools for early cancer detection,” says Bill Behnke, founder and CEO of Cizzle Bio, in a release. “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.”
Prior research on the assay reported 95% sensitivity for detecting stage I lung cancer and a 96% negative predictive value, according to the company.
Lung cancer is the leading cause of cancer-related deaths globally, with more than 229,000 new cases expected in the US in 2026, according to the American Cancer Society. Five-year survival rates are approximately 65% when the disease is detected early, but fall to 10% when diagnosed at advanced stages, according to the American Lung Association.
While approximately 14.2 million Americans are eligible for annual screening, uptake remains low, and LDCT can produce false positives that lead to unnecessary follow-up procedures, according to the press release. The biomarker test may enhance risk stratification and reduce diagnostic uncertainty.
“We are committed to bringing high-quality diagnostic solutions into clinical practice,” says Steve Kamalic, CEO of OmniHealth Diagnostics, in a release. “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.”
The test is built on more than 30 years of research led by Dawn Coverley, PhD, at the University of York. It is currently being evaluated in clinical studies with National Cancer Institute designated cancer centers, including Moffitt Cancer Center.
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