EXoPERT
EXoPERT has developed a liquid biopsy-based in vitro diagnostic medical device that can diagnose cancer through blood. The in vitro diagnostic medical device for this clinical performance trial is a test device that applies a technology that measures Raman spectroscopic signals of extracellular vesicles in the blood and classifies high-risk and low-risk patients for breast cancer through artificial intelligence analysis. The test device used in this clinical performance trial is expected to assist in the differential diagnosis of high-risk and low-risk breast cancer patients by developing a software algorithm for an in vitro diagnostic medical device for auxiliary diagnosis that classifies high-risk and low-risk breast cancer patients and confirming the clinical efficacy and safety of the device through this clinical performance trial.
According to the Korean Breast Cancer Society, when comparing the five-year survival rate of breast cancer patients by stage from 2001 to 2012, the survival rate is 98.3% for stage 0, 96.6% for stage 1, and 91.8% for stage 2, but the survival rate for stage 4 patients with systemic metastasis is 34%. Therefore, early detection and accurate diagnosis are very important for breast cancer treatment. Currently, breast cancer is diagnosed through breast ultrasound and mammography. These imaging modalities are defined by the American College of Radiology's Breast Imaging Reporting and Data System (…
Inclusion Criteria(Breast malignant nodule group) 1. Korean nationality 2. Voluntary written consent to participate in this clinical performance trial study 3. Confirmed breast cancer through imaging/pathologic diagnostic tests 4. Those who have been diagnosed with breast cancer at a stage prior to treatment and surgery, and who agree to participate in this study and are able to provide blood samples. 5. Those whose lesions have been confirmed by conventional examination (breast ultrasound or mammography) and who fall into BI-RADS categories 4,5,6 and have undergone biopsy or are scheduled to…
Performing in vitro diagnostics with devices developed by EXoPERT