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Genobio CTC Kit Cleared by Korean Regulators

NEW YORK (360Dx) – South Korean companion diagnostics development firm Genobio said this week that its GenoCTC isolation kit has been cleared by the Korean Ministry of Food and Drug Safety for marketing in that country.

It was cleared as a reagent for an in vitro diagnostic device, Genobio said.

GenoCTC isolates epithelial cell adhesion molecule [EpCAM]-positive cells from liquid biopsies. According to Genobio, EpCAMs are "extensively expressed" on the cells of epithelial origin and serve as biomarkers for these cells in blood. The isolation kit can sort highly rare EpCAM-positive CTCs in blood and can be used to isolate carcinoma cells.

The company said that in order to achieve regulatory clearance, it conducted a series of in vitro experiments using cancer cell line spike tests in normal blood samples and showed "100 percent efficiency in isolating EpCAM-positive cells."

GenoCTC was developed for use on Genobio's CTC isolation device called GenoCTC II. The company plans to seek US Food and Drug Administration clearance for the kit, and it plans a clinical trial in the US for its companion diagnostic devices, Genobio CEO Seok Bom Ko said in a statement.