[Asia Economy Reporter Hyunseok Yoo] GenCurix is showing strong performance. This is interpreted as being influenced by the news that the breast cancer prognosis diagnostic kit ‘Jinswell BCT’ received approval as an innovative medical technology from the National Evidence-based Healthcare Collaborating Agency (NECA) under the Ministry of Health and Welfare. With this approval, the introduction of the product in domestic general hospitals is expected to accelerate, and coverage by indemnity health insurance will also become possible.
As of 10:31 AM on the 15th, GenCurix was trading at 19,500 KRW, up 3.72% (700 KRW) compared to the previous trading day.
To sell medical devices incorporating new technologies in domestic general hospitals, approval as innovative medical technology or new medical technology is required in addition to the Ministry of Food and Drug Safety (MFDS) approval. The innovative medical technology evaluation system was introduced by the Ministry of Health and Welfare in March last year to facilitate early market entry of innovative medical technologies.
The evaluation is conducted over approximately nine months through a rigorous process focusing on potential value assessments such as ▲innovation of the medical technology ▲social demand ▲importance of the disease ▲and the physical and economic burden on patients. Following MFDS approval, this innovative medical technology approval enables formal coding-based prescriptions of Jinswell BCT in domestic general hospitals, raising expectations for substantial sales growth. This latest approval further confirms the excellent performance and reliability of Jinswell BCT beyond the MFDS approval.
Breast cancer prognosis diagnostic tests are technologies that help determine whether patients who have undergone breast cancer excision surgery require additional chemotherapy. A company official explained, “Currently, the breast cancer prognosis diagnostic test most commonly used by patients is from the US company E, but it has not received domestic approval due to the lack of clinical results targeting Asian patients.” He added, “Even if doctors want to recommend it to patients, the absence of clinical data for Korean patients and the high cost exceeding 4 million KRW without insurance coverage have hindered active sales.”
On the other hand, Jinswell BCT is the only breast cancer prognosis diagnostic test in Asia that has proven efficacy through multiple clinical trials and obtained formal sales approval. When covered by indemnity health insurance, the patient’s out-of-pocket expense is lower compared to competing products, enabling market expansion based on test accuracy and price competitiveness. Furthermore, as the first diagnostic kit developed specifically for East Asians in breast cancer, where racial differences between East and West are significant, the company plans to solidify its dominant No.1 position in the rapidly growing Asian market based on its excellent technology.
A company representative stated, “Several general hospitals have expressed their intention to actively adopt Jinswell BCT following the innovative medical technology approval,” and added, “With this approval, we will strive to establish prognosis diagnostics as a standard test for domestic breast cancer patients, just as in advanced countries.”
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