Evaluation of an innovative multi-cancer early detection test: high sensitivity and specificity in differentiating cancer, inflammatory conditions, and healthy individuals

Abstract

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: cancer screening; diagnostic; liquid biopsy; multi-cancer early detection; plasma protein test.

Figure 1

Extinction units assessed with the Carcimun® test shown for the three groups of participants. The extinction threshold of 120 U to differentiate cancer patients is shown as the red dotted line.

Figure 2

Overview of true negative and true positive values of the Carcimun® test PPV, positive predictive value; NPV, negative predictive value.