The EG-Breast Blood Test-P1, developed by EG BioMed Co. Ltd., has demonstrated outstanding performance with over 90% sensitivity and accuracy in monitoring disease progression in breast cancer patients during follow-up. This comprehensive study was conducted between 2016 and 2023 in Taipei, Taiwan, and involved over 400 breast cancer patients with follow-up periods ranging from one to five years. The study also included Western populations, enrolling more than 500 plasma samples from breast cancer patients to explore the potential of circulating cell-free DNA (ccfDNA) in predicting breast cancer progression.
By extracting ccfDNA and measuring the methylation levels of candidate genes, we developed a predictive model. The overall findings highlight that the assay’s precision, repeatability, specificity, and stability exceed 95%, with a limit of detection set lower than 0.2 pg/μL, unaffected by common blood interferences. These attributes establish the EG-Breast Blood Test-P1 as a precise and stable predictive tool, offering a novel, noninvasive method for effectively monitoring breast cancer progression through the detection of specific biomarkers. This could significantly enhance early diagnosis and management of breast cancer, potentially improving patient outcomes by facilitating timely interventions based on reliable, rapid test results.
This innovative product, EG-Breast Blood Test-P1, has been submitted to the FDA De Novo pathway and is currently under review.