[Asia Economy Reporter Hyunseok Yoo] Molecular diagnostics specialist GenCurix announced on the 6th that it has completed the application for approval of the thyroid cancer companion diagnostic kit ‘Droplex BRAF Mutation Test’ with the Ministry of Food and Drug Safety.
Thyroid cancer is the most prevalent cancer type in South Korea, with over 30,000 new cases annually. The product for which approval was applied tests for the presence of mutations in codon 600 of the BRAF gene, which commonly occur in thyroid cancer patients, using digital PCR (polymerase chain reaction) technology. This is an advanced diagnostic test with approximately 100 times higher sensitivity compared to conventional RT (real-time) PCR.
The company stated, “We expect to complete approval for the BRAF companion diagnostic product within the first quarter,” adding, “Since major domestic hospitals such as Samsung Seoul Hospital, Sinchon Severance, and Bundang Seoul National University Hospital have introduced digital PCR equipment along with the EGFR companion diagnostic test last year, sales of subsequent products are expected to be smoother.”
They continued, “In advanced countries including the United States, companion diagnostic testing is mandatory for prescribing targeted anticancer drugs, making the requirement for companion diagnostics a global trend,” and “We will focus on developing products for various cancer types following non-small cell lung cancer and thyroid cancer to secure a global competitive edge in the rapidly growing companion diagnostics market.”
Meanwhile, GenCurix announced on the 3rd that it obtained export approval from the Ministry of Food and Drug Safety for the world’s first digital PCR-based non-small cell lung cancer target cMET companion diagnostic kit, ‘Droplex cMET Exon14 Skipping’.
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