Revolutionary Early Lung Cancer Blood Test to Enable Faster Treatment

Lung cancer is one of the most prevalent cancers globally, with over 2 million new cases reported in 2018. Unfortunately, the majority of lung cancer cases have already metastasized by the time they are diagnosed. CT scans, which are commonly used for diagnosis, have a false positive rate of about 90%, depending on the referral process. These false positives often lead to unnecessary and costly further tests, which are typically repeated multiple times. Many of these tests are invasive, causing considerable trauma to patients. Currently, there is no approved blood-based biomarker for the early detection of lung cancer in the NHS. To address these challenges, researchers have developed a prototype blood test for diagnosing lung cancer that could help reduce false positive rates from CT scans, potentially preventing unnecessary invasive procedures and costs.

Cizzle Biotechnology (London, UK) is working on a non-invasive, affordable blood test that leverages a naturally occurring cell nuclear protein, CIZ1, which plays a role in DNA replication. A specific variant of CIZ1, known as CIZ1B, has been strongly linked to early-stage cancer presence. Cizzle's proprietary CIZ1B biomarker assay for patients with suspicious lung nodules represents a major advancement in the fight against lung cancer. This test could replace the current expensive, time-consuming, and invasive diagnostic process. Cizzle is conducting an extensive clinical evaluation of the CIZ1B biomarker lung cancer test in a high-volume, real-world clinical setting. The goal is to obtain CLIA accreditation for the test by the end of 2024, with a full launch in North America planned for April 2025.

Image: The test is intended for the early detection of lung cancer when curative surgical resection is possible (Photo courtesy of Cizzle Biotechnology)

The results from this and other planned evaluations could further demonstrate the test’s potential to distinguish between malignant and benign lung nodules, making it more widely applicable in clinical settings. Initially, the product will be an immunoassay for use in hospitals and reference laboratories, with the possibility of a point-of-care version for primary healthcare providers in the future. This test is designed to address a critical gap in clinical practice—the early detection of lung cancer when surgical removal is still a viable option. Given that nearly 5,000 people die from lung cancer daily worldwide, early detection is crucial. Cizzle's CIZ1B biomarker blood test offers a cost-effective, non-invasive solution to detect lung cancer in its earliest stages, potentially saving lives and reducing healthcare costs.

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