{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,13]],"date-time":"2026-06-13T01:52:07Z","timestamp":1781315527559,"version":"3.54.1"},"reference-count":29,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2025,3,6]],"date-time":"2025-03-06T00:00:00Z","timestamp":1741219200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Oncol."],"abstract":"<jats:sec><jats:title>Background<\/jats:title><jats:p>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<jats:sup>\u00ae<\/jats:sup> test was reported, detecting conformational changes in plasma proteins through optical extinction measurements. This study evaluates the Carcimun<jats:sup>\u00ae<\/jats:sup> test\u2019s performance, including participants with inflammatory conditions.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>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<jats:sup>\u00ae<\/jats:sup> test. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were calculated.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>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&amp;lt;0.001). The Carcimun<jats:sup>\u00ae<\/jats:sup> 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&amp;lt;0.001), and between cancer patients and those with inflammation (p&amp;lt;0.001).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>The Carcimun<jats:sup>\u00ae<\/jats:sup> 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\u2019s robustness in real-world clinical scenarios. These findings underscore the potential of the Carcimun<jats:sup>\u00ae<\/jats:sup> test as a valuable tool for early cancer detection and screening.<\/jats:p><\/jats:sec>","DOI":"10.3389\/fonc.2025.1520869","type":"journal-article","created":{"date-parts":[[2025,3,6]],"date-time":"2025-03-06T05:11:13Z","timestamp":1741237873000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":8,"title":["Evaluation of an innovative multi-cancer early detection test: high sensitivity and specificity in differentiating cancer, inflammatory conditions, and healthy individuals"],"prefix":"10.3389","volume":"15","author":[{"given":"Nike","family":"Walter","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J\u00f6rg","family":"Groth","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Berthold von und zu","family":"Zwerger","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2025,3,6]]},"reference":[{"key":"B1","doi-asserted-by":"publisher","DOI":"10.3322\/caac.21834","article-title":"Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries","volume":"74","author":"Bray","year":"2024","journal-title":"CA Cancer J Clin"},{"key":"B2","doi-asserted-by":"publisher","DOI":"10.1126\/science.aay9040","article-title":"Early detection of cancer","volume":"375","author":"Crosby","year":"2022","journal-title":"Science"},{"key":"B3","doi-asserted-by":"publisher","DOI":"10.3322\/caac.21713","article-title":"Molecular imaging in oncology: current impact and future directions","volume":"72","author":"Rowe","year":"2022","journal-title":"CA Cancer J Clin Juli"},{"key":"B4","doi-asserted-by":"publisher","DOI":"10.1007\/s40273-022-01181-3","article-title":"The potential value-based price of a multi-cancer early detection genomic blood test to complement current single cancer screening in the USA","volume":"40","author":"Tafazzoli","year":"2022","journal-title":"Pharmacoeconomics. 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