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.
Korean nationality
Voluntary written consent to participate in this clinical performance trial study
Confirmed breast cancer through imaging/pathologic diagnostic tests
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.
Those who have been diagnosed with cancer (malignant tumor) of any type within 5 years of the date of consent and have undergone appropriate chemotherapy/radiation treatment or surgery.
Those who are confirmed to have developed breast cancer due to metastasis from malignant tumors other than breast cancer
Pregnant women
Participation in a drug-related clinical trial within 3 months of the date of the informed consent form