Amadix presented the validation of the PreveCol predictive model through a European prospective clinical study involving an average-risk population actively engaged in a real CRC screening program. AMADIX has developed PreveCol, an innovative blood test based on molecular biomarkers and clinical features for the early detection of colorectal cancer (CRC) and advanced adenoma (AA), before the onset of the first symptoms.

For CRC detection, PreveCol demonstrated an area under the ROC curve (AUC) of 92%, with a sensitivity of 81.8% and specificity of 86%. Moreover, the model exhibits high sensitivity (above 90%) in identifying CRC in early stages (stages 1 and 2), as well as lesions located in the proximal colon. Additionally, the AUC of PreveCol for advanced adenoma detection was 86.88% (sensitivity of 70.8% and specificity of 86%), showing that PreveCol presents higher sensitivity to other identified tests for detecting precancerous lesions.

In March 2023, Amadix launched its first product, PreveCol, for the early detection of colon cancer. HM Hospitals and the company joined forces to promote the hyper-early detection of colorectal cancer in asymptomatic people. The test is available at the three HM CIOCC headquarters in Madrid, Barcelona, and Galicia and the rest of the HM Hospitales Group centers, and is aimed at patients between 50 and 75 years old, who want to detect the onset of the disease early.   

In January 2024, Amadix announced that PreveCol received Breakthrough Device Designation from the US FDA. With this milestone, Amadix became the first European company to announce this recognition for early detection of colorectal cancer.

Conclusion

These findings highlighted PreveCol’s potential to significantly impact patient prognosis and survival by facilitating the early detection of CRC and premalignant lesions, as well as lesions in critical areas of the colon. This contribution to improved screening efficacy and patient outcomes underscores the importance of PreveCol in clinical practice. PreveCol consists of a blood test, which does not require prior intestinal preparation or sedation, unlike other invasive tests such as colonoscopy. This improves patient adherence to screening programs and, therefore, the prevention of colorectal cancer.