Zencurix Completes MFDS Export Approval for Endometrial Cancer Diagnostic Kit... 'Pipeline Expansion'

[Asia Economy Reporter Hyunseok Yoo] Liquid biopsy molecular diagnostics specialist GenCurix announced on the 30th that it has obtained export approval from the Ministry of Food and Drug Safety for its self-developed endometrial cancer diagnostic kit, ‘Droplex POLE Mutation Test’ (hereinafter referred to as Droplex POLE).

Droplex POLE is a product that detects the five major driver mutation genes causing cancer in tissue samples from patients with endometrial cancer. The POLE test is conducted with the purpose of reducing unnecessary chemotherapy for endometrial cancer patients and enabling immune-targeted therapy.

The company stated, “Despite the rapidly increasing number of endometrial cancer patients, there is currently no POLE diagnostic kit approved in the global market,” and added, “With the export approval of the endometrial cancer kit following three existing companion diagnostic kits (lung cancer, thyroid cancer, colorectal cancer), the Droplex portfolio has been further strengthened for entry into the global companion diagnostics market.”

Endometrial cancer is a cancer that occurs due to genetic mutations in the endometrial cells lining the uterine cavity. In South Korea, the number of endometrial cancer patients has increased more than fourfold over the past 20 years. It ranks fourth in prevalence and mortality among WHO-listed female cancers.

Meanwhile, the company previously obtained export approval from the Ministry of Food and Drug Safety in May for companion diagnostic kits targeting lung cancer (Droplex EGFR Mutation Test v2), thyroid cancer (Droplex BRAF Mutation Test), and colorectal cancer (Droplex KRAS Mutation Test).