GenCurix Launches Sales as Lung Cancer Companion Diagnostic Kit Covered by Health Insurance

[Asia Economy Reporter Yoo Hyun-seok] GenCurix announced on the 7th that the Health Insurance Review and Assessment Service has completed the insurance fee review for its self-developed lung cancer companion diagnostic kit, Jinswell ddEGFR. Accordingly, health insurance coverage will be applied immediately from this month, and sales are expected to be in full swing.

Jinswell ddEGFR is a test that uses blood to detect the presence of mutations in 47 epidermal growth factor receptor (EGFR) genes in patients with non-small cell lung cancer. By analyzing genomic information through test results, it enables personalized treatment by selecting patients who respond to specific targeted anticancer drugs such as AstraZeneca's Tagrisso or Roche's Tarceva.

In particular, Jinswell ddEGFR utilizes a third-generation platform, digital PCR (polymerase chain reaction), which is more than 50 times more sensitive and accurate than the conventional RT-PCR (real-time PCR) method. With this health insurance coverage, diagnostic kits with performance far superior to the existing RT-PCR method can be sold at the same patient cost. Based on technological and performance superiority in the lung cancer companion diagnostic field, significant market share expansion is expected.

Currently, Jinswell ddEGFR detects 47 cancer-specific mutations, enabling more diverse diagnostics compared to competing products. Notably, it is the only approved test capable of detecting the ‘C797S’ mutation, which causes resistance to AstraZeneca's Tagrisso, a representative lung cancer targeted anticancer drug.

Additionally, performance has been improved to detect over 100 mutations at once, and a next-generation product that can be tested with a small amount of blood instead of tissue has been developed and is planned for release within the year. Beyond lung cancer, test products targeting other cancers such as colorectal cancer and melanoma have also been developed, and after obtaining approval from the Ministry of Food and Drug Safety within the year, the digital PCR product portfolio will be further strengthened.

Jang Sang-rae, CEO of GenCurix, stated, “We have secured price competitiveness along with advanced diagnostic technology in the lung cancer companion diagnostic field. The new products to be launched this year will detect mutations with a small amount of blood through liquid biopsy technology and enable easy anticancer treatment monitoring by selecting the optimal anticancer drug, allowing us to rapidly expand market share.”

Meanwhile, GenCurix received manufacturing and product approval from the Ministry of Food and Drug Safety for Jinswell ddEGFR in 2017, followed by recognition as a new medical technology by the National Evidence-based Healthcare Collaborating Agency (NECA) in 2018. Last year, it also obtained European medical device certification (CE-IVD), laying the foundation for global market entry.