Gencurix gets FDA OK for breast cancer prognosis analysis device
Ye-Na Kim
Nov 08, 2023 (Gmt+09:00)
South Korean biotech company Gencurix Inc. announced on Wednesday its subsidiary GenoBio has received approval from the US Food and Drug Administration (FDA) for the "GenoCTC v5," a circulating tumor cells (CTCs)-based breast cancer prognosis analysis device.
According to Gencurix, CTCs are tumor cells found in the blood, which are used for monitoring cancer treatment effectiveness and as markers for cancer metastasis.
GenoBio had previously presented research results at the San Antonio Breast Cancer Symposium in December last year, predicting the prognosis of breast cancer patients using this device.
Gencurix reported that GenoBio is currently working on the commercialization of various testing services based on CTCs and is conducting clinical trials for anticancer drug treatment response and recurrence monitoring for not only breast cancer but also lung cancer, colorectal cancer, and bile duct cancer.
Gencurix commented that this approval has established a foundation to conduct clinical trials in the US based on GenoCTC.