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.