Advancing Early Detection of Lung Cancer – Moffitt Cancer Center’s Clinical Trial of the CIZ1B Biomarker-Based Blood Test
Early detection is critical in improving survival rates for lung cancer—the leading cause of cancer deaths worldwide with more than 234,000 new cases diagnosed in the United States each year. A promising clinical trial is underway at Moffitt Cancer Center in Tampa, Florida, to study the CIZ1B biomarker-based blood test—an early-detection tool that could transform how physicians diagnose and monitor lung cancer. “A reliable biomarker blood test could significantly enhance lung cancer detection, serving as a minimally invasive tool to guide further evaluation,” explained Lary Robinson, M.D., director of Moffitt’s Lung Cancer Early Detection Center (LEAD) and the clinical trial’s principal investigator. “As an adjunct diagnostic tool, it could help to ensure early diagnosis, reduce delayed intervention, and improve patient outcomes.”
Need for Improved Early Detection
Lung cancer is often diagnosed at advanced stages, when treatment options are limited, and survival rates are low. “While a low-dose CT (LDCT) scan remains the standard protocol for early detection, only about 15% of individuals who meet the recommended screening guidelines undergo the test, often due to accessibility, concerns about cost, and fear of diagnosis,” Robinson said. Additionally, LDCT scans can produce false positives, leading to invasive procedures. “At least 20% of nodules identified with LDCT are benign, while only about 4% of positive scans indicate a malignancy—so there is a significant percentage of false positives,” he added.
Another challenge with lung cancer detection is that current screening guidelines from the U.S. Preventive Task Force do not include everyone at risk. According to Robinson, even if every high-risk individual in the United States underwent an LDCT, only about 65% of lung cancer cases would be detected. “That means up to 35% of lung cancers occur in people who don’t meet the current screening criteria, representing a significant gap in early diagnosis,” Robinson said. This gap highlights the need for additional early-detection tools, such as a biomarker-based blood test, to identify lung cancer in a broader population.
A New Diagnostic Tool
The CIZ1B biomarker blood test is based on years of research into the CIZ1 gene at the University of York that identified the CIZ1B protein variant and its strong association with early-stage lung cancer. A UK-based clinical trial has shown the CIZ1B biomarker test to be highly accurate, with sensitivity at 95% for Stage I detection and Negative Predictive Value (NPV) at 96%. Using less than a tablespoon of blood, the test provides a minimally invasive and accessible diagnostic tool that can provide an additional data point to enhance the current diagnostic protocol. Cizzle Bio, Inc., holds the exclusive license for the proprietary CIZ1B biomarker test and is leading commercialization efforts in the United States.
The current clinical trial at Moffitt, conducted in conjunction with Cizzle Bio licensing partner, UK-based Cizzle Biotechnology PLC, is a retrospective analysis of 250 patients with identified lung nodules that will provide key insights into the predictive value of the CIZ1B biomarker test—both for initial diagnosis and long-term monitoring. Results of the blood test from patients’ initial evaluation will be compared with actual clinical findings, and the blood test will be repeated in follow-up visits during three-year surveillance of patients who have had curative lung cancer treatment.
Robinson said that an accurate biomarker-based blood test has profound implications for improving lung cancer diagnosis. “A reliable blood test could help assess indeterminate, or unknown, lung nodules, reducing unnecessary invasive procedures,” he said, adding that a blood test could also provide an early warning system for cancer recurrence. He emphasized the potential clinical value of a blood test in accelerating diagnosis and treatment. “With a highly sensitive and specific test, some patients might move directly to surgery rather than waiting for additional evaluations,” Robinson said. “That kind of speed matters because the earlier we diagnose and treat lung cancer, the better the chance for survival.”
