(1) EarlyFound® MMP-1 ELISA kit
-Quantitative data (concentration)
-Easy performed in clinical lab
-Suitable for high throughput test
-Validation in 1,031 saliva specimens
-Sensitivity: 85.6% (95% CI: 81.4–89.0%)
-Specificity: 78.7% (95% CI: 75.5–81.6%)
-Accuracy: 80.9% (95% CI: 78.4–83.2%)
-Use scenario:Utilized with ELISA reader equipment within hospitals for the auxiliary diagnosis of oral cancer and for monitoring the prognosis of oral cancer.
-Obtained medical device approvals from CE (IVDD), Singapore HSA, Australia TGA, Hong Kong MDD, Thailand FDA, and Vietnam MoH.
(2) EarlyFound® MMP-1 Rapid Strip Test
-Qualitative data
-Easy performed by oneself
-Suitable for point-of-care test
-Validation in 1,029 saliva specimens
-Sensitivity: 79.8% (95% CI: 75.1–83.8%)
-Specificity: 86.2% (95% CI: 83.5–85.6%)
-Accuracy: 84.2% (95% CI: 81.8–86.3%)
-Use scenario:For first-line oral cancer screening and suitable for use in out-of-hospital settings.
-Obtained medical device approval under CE (IVDD); registration reviews are currently in progress with Singapore HSA, Australia TGA, and Hong Kong MDD.