Gene Solutions has completed the K-DETEK trial, making SPOT-MAS the first multi-cancer early detection (MCED) blood test in Asia to be prospectively validated in a large-scale clinical study.
- Clinical Validation: The K-DETEK trial followed 9,024 asymptomatic participants over 12 months, demonstrating an overall sensitivity of 70.8% for cancerous lesions and a specificity of 99.7%.
- Predictive Accuracy: The test achieved a negative predictive value of 99.92% and successfully identified precancerous lesions in the digestive tract, reaching a combined sensitivity of 78.1% for both malignant and precancerous cases.
- Regional Significance: Published in BMC Medicine, the study provides specific clinical data for Asian populations, supporting the test’s utility in regions where late-stage diagnosis remains a significant challenge.
This summary is based on a press release issued by Gene Solutions Genomics Pte Ltd.