Zencurix Receives MFDS Approval for Thyroid Cancer Mutation Test 'BRAF Test'

[Asia Economy Reporter Jang Hyowon] Genecurix announced on the 8th that it has received manufacturing approval from the Ministry of Food and Drug Safety (MFDS) in Korea for the thyroid cancer mutation test, ‘Droplex BRAF Mutation Test’.

The Droplex BRAF Mutation Test is a product that detects the presence of the BRAF gene Codon 600 (V600E) mutation, which frequently occurs in thyroid cancer patients, using digital PCR technology. Following the breast cancer prognosis diagnostic kit GenesWell BCT and the lung cancer companion diagnostic kit GenesWell ddEGFR Mutation Test, this is the third product from Genecurix to receive domestic manufacturing approval.

Thyroid cancer is the most prevalent cancer type in Korea, with over 30,000 new cases annually. The most commonly observed genetic mutation related to thyroid cancer is the BRAF mutation, with the BRAF V600E mutation accounting for more than 98% of cases. Additionally, research and development and drug approvals utilizing BRAF mutations have been made in the fields of melanoma, non-small cell lung cancer (NSCLC), and colorectal cancer targeted therapies, leading to expectations that the use of Genecurix’s Droplex BRAF Mutation Test will expand further in the future.

Director Kang Miran stated, “The Droplex test features the application of the latest digital PCR technology instead of conventional RT-PCR, demonstrating sensitivity more than 50 times higher.” She added, “Companion diagnostic products for lung cancer (Droplex EGFR Mutation Test v2), colorectal cancer (Droplex KRAS Mutation Test), and endometrial cancer (Droplex POLE Mutation Test) are currently under MFDS approval review, and we expect additional approvals within this year.”

Meanwhile, the company completed European CE registration for a total of eight companion diagnostic tests in the first half of this year, including the thyroid cancer mutation test, lung cancer (Droplex EGFR Mutation Test v2), and colorectal cancer (Droplex KRAS Mutation Test). Through global sales and marketing cooperation with the global diagnostic equipment company Bio-Rad, Genecurix is accelerating the overseas market entry of Droplex.

This content was produced with the assistance of AI translation services.