EG-Breast Blood Test-P1 Breast Cancer Follow-Up Blood Test

Model: EG-Breast Blood Test-P1

Booth No: M710

Characteristic

Technology Overview：
EG BioMed has developed a non-invasive, high-throughput circulating cell-free DNA (cfDNA) analysis platform that integrates fully automated cfDNA extraction with high-sensitivity blood testing for breast cancer. Powered by proprietary high-specificity methylation probes and quantitative PCR (qPCR) analysis, this platform leverages precise DNA methylation biomarkers to enable longitudinal monitoring of breast cancer.
The entire process is standardized and automated, requiring only 8 milliliters of peripheral blood with no invasive procedures. Test results with high sensitivity and specificity can be delivered in as little as two business days. This technology is specifically designed for post-surgical and post-treatment breast cancer patients, making it well-suited for large-scale clinical adoption. It also serves as a practical tool for disease monitoring and recurrence risk assessment, offering a faster, simpler, and highly accurate blood-based solution for breast cancer management.The technology is protected by patents granted in multiple countries, demonstrating strong potential for international adoption and clinical implementation.

Clinical Use Cases：
•Post-surgical or post-treatment follow-up
Helps physicians detect recurrence or metastasis early and take action sooner.
•Assessment of treatment efficacy
After radiation, chemotherapy, or targeted therapy, the test can be used periodically to detect any residual cancer cell activity.
•When imaging or tumor markers are inconclusive
DNA methylation analysis offers molecular-level insights to support clearer clinical decision-making when traditional indicators are
uncertain.

Key Advantages：
•Non-invasive: Requires only a blood draw, high patient acceptance
•Standardized automation: Rapid and consistent results with minimal error
•Repeatable and trackable: Ideal for ongoing follow-up and personalized care
•Globally patented: Strong foundation for international clinical collaboration

Clinical Performance：
This test has been validated in over 500 clinical samples and demonstrated excellent diagnostic accuracy:
•Sensitivity: 95.7%
•Specificity: 90.3%
•Overall accuracy: 91.5%
The application has been submitted to the U.S. FDA under the De Novo pathway. At the same time, the technology complies with ISO 15189 standards and meets the requirements for Laboratory Developed Tests (LDTs), supporting its readiness for clinical implementation.

Patent Strategy & Global Expansion：
EG BioMed has pursued an extensive global IP strategy since 2019:
• 2021: Taiwan patent granted
• 2023: EU patent granted and registered across 19 European countries
• 2024: Patents granted in Malaysia and China
• 2025: Patents granted in the U.S., Japan, Singapore, and Australia
Additional international patent applications are under review, establishing a comprehensive global protection framework to support future clinical adoption and licensing partnerships.

Market Demand & Clinical Urgency：
United States (CDC data):
•Over 1.5 million breast cancer survivors currently under 5-year follow-up
•Estimated 310,720 new breast cancer diagnoses in 2024
Taiwan (Ministry of Health and Welfare):
•Over 75,000 breast cancer survivors currently under 5-year follow-up
•17,432 new breast cancer diagnoses in 2022
Studies show that approximately 20–30% of early-stage breast cancer patients will eventually develop metastatic breast cancer. A stable and accurate follow-up method is urgently needed in clinical care.

Currently, there is still a lack of a reliable, repeatable, and non-invasive follow-up method for post-treatment breast cancer patients. We believe this blood test fills that gap—giving physicians greater confidence and empowering patients to move from passive waiting to actively managing their health.