TL/DR –
Cizzle Bio has completed the laboratory validation of its CIZ1B biomarker blood test for early detection of lung cancer at the OmniHealth Diagnostics lab in Dallas, Texas. The test, which identifies a protein variant associated with early-stage lung cancer, will be used alongside low-dose computed tomography screening and other diagnostic methods to help clinicians assess cancer risk and clarify indeterminate findings. Previous research reported the assay having 95% sensitivity for detecting stage I lung cancer and a 96% negative predictive value.
Cizzle Bio Announces Validation of Early Lung Cancer Detection Test
Cizzle Bio recently affirmed the lab validation of its CIZ1B biomarker blood test for early lung cancer detection at OmniHealth Diagnostics, a Dallas-based clinical lab. The validation completion prepares the test for availability to US healthcare providers.
About the CIZ1B Biomarker Blood Test
This enzyme-linked immunosorbent assay identifies a protein variant linked with early-stage lung cancer. The test requires less than a tablespoon of blood and complements low-dose computed tomography (LDCT) screening and other standard diagnostic methods to enhance cancer risk assessment and clarify indeterminate findings.
Lab Validation and Clinical Use
The assay, being a laboratory-developed test, needs validation by any Clinical Laboratory Improvement Amendments certified facility. OmniHealth Diagnostics, a Katharos Health family member, also accredited by the Commission on Office Laboratory Accreditation, verified the test’s readiness for clinical use in the US.
Importance of Early Detection
Cizzle Bio’s mission to broaden access to innovative tools for early cancer detection gets a boost with the CIZ1B lab validation. The blood-based biomarker test aims to bridge the early detection gap and help patients and their healthcare providers make better-informed decisions about subsequent care steps.
Previous research shows the assay has a 95% sensitivity in detecting stage I lung cancer and a 96% negative predictive value.
Worldwide, lung cancer is the leading cause of cancer-related deaths, with over 229,000 new cases anticipated in the US in 2026. According to the American Lung Association, early detection ups the five-year survival rates to approximately 65% from 10% at advanced stages.
Despite around 14.2 million Americans being eligible for annual screening, uptake remains low. LDCT can produce false positives, leading to unnecessary follow-up procedures. The biomarker test could enhance risk stratification and reduce diagnostic uncertainty.
Cizzle Bio and OmniHealth Diagnostics Partnership
OmniHealth Diagnostics’ CEO, Steve Kamalic, voiced his company’s commitment to delivering quality diagnostic solutions into clinical practice. He expressed pride in partnering with Cizzle Bio to expand access to a new biomarker tool for earlier lung cancer identification.
The test is a product of over 30 years of research led by Dawn Coverley, PhD, at the University of York. Clinical evaluations are ongoing in National Cancer Institute designated cancer centers, including Moffitt Cancer Center.
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