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ORIGINAL RESEARCH article
Front. Oncol.
Sec. Molecular and Cellular Oncology
Volume 15 - 2025 | doi: 10.3389/fonc.2025.1520869
This article is part of the Research Topic Early Detection, Cancer Interception, Et Al: Translating the Multifaceted Use of Liquid Biopsy to the Management of Early Disease View all 4 articles
Evaluation of an Innovative Multi-Cancer Early Detection Test: High Sensitivity and Specificity in Differentiating Cancer, Inflammatory Conditions, and Healthy Individuals
Provisionally accepted- 1 University Medical Center Regensburg, Regensburg, Germany
- 2 DRK Hospital Neuwied, Neuwied, Germany
- 3 Practice for Naturopathy,, Garmisch-Partenkirchen, Germany
Background: Cancer is a leading cause of death worldwide, with early detection crucial for effective treatment. Traditional diagnostic methods, such as imaging and biopsies, are often limited by invasiveness, cost, and sensitivity. Blood-based multi-cancer early detection (MCED) tests offer a less invasive and potentially more comprehensive approach. Recently, a novel screening tool, the Carcimun® test was reported, detecting conformational changes in plasma proteins through optical extinction measurements. This study evaluates the Carcimun® test's performance, including participants with inflammatory conditions. Methods: This prospective, single-blinded study included 172 participants: 80 healthy volunteers, 64 cancer patients (various types), and 28 individuals with inflammatory conditions (fibrosis, sarcoidosis, pneumonia) or benign tumors. Plasma samples were analyzed using the Carcimun® test. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were calculated. Results: Mean extinction values were significantly higher in cancer patients (315.1) compared to healthy individuals (23.9) and those with inflammatory conditions (62.7) (p<0.001). The Carcimun® test distinguished these groups with high accuracy (95.4%), sensitivity (90.6%), and specificity (98.2%). Significant differences were found between healthy participants and cancer patients (p<0.001), and between cancer patients and those with inflammation (p<0.001). Conclusion: The Carcimun® test achieved high accuracy, sensitivity, and specificity, effectively identifying cancer patients while minimizing false positives and negatives. By including participants with inflammatory conditions, we addressed a significant limitation of previous studies, demonstrating the test's robustness in real-world clinical scenarios. These findings underscore the potential of the Carcimun® test as a valuable tool for early cancer detection and screening.
Keywords: multi-cancer early Detection, liquid biopsy, diagnostic, cancer screening, plasma protein test
Received: 31 Oct 2024; Accepted: 11 Feb 2025.
Copyright: © 2025 Walter, Groth and Zwerger. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Nike Walter, University Medical Center Regensburg, Regensburg, Germany
Jörg Groth, DRK Hospital Neuwied, Neuwied, Germany
Berthold Zwerger, Practice for Naturopathy,, Garmisch-Partenkirchen, Germany
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.