[E-Daily Reporter NA EUN-KYUNG ] Genomictree Inc.(228760)’s bladder cancer diagnostic device, EarlyTec-B, obtained a manufacturing license from the Ministry of Food and Drug Safety last January and simultaneously secured CE-IVDR certification—the European in vitro diagnostic regulation—demonstrating both its technological capabilities and its ability to comply with global regulations.

The company is accelerating its efforts to apply for a deferral of the new medical technology evaluation, aiming to enable non-insured prescriptions not only at health screening centers but also at general medical institutions. It is expected to complete the approval process as early as July, with actual prescriptions expected to be possible starting this August.

“EarlyTec-B Plus,” which detects even early-stage bladder cancer

Currently, when a patient presents with hematuria, a cystoscopy is virtually the standard procedure. However, since the majority of patients with hematuria are found not to have bladder cancer, the resulting patient inconvenience and financial burden have long been identified as challenges that need to be addressed.

EarlyTec-B is designed as a molecular diagnostics-based “precision triage solution” that uses a high negative predictive value (NPV) to screen out patients with a low likelihood of bladder cancer, thereby reducing unnecessary cystoscopy procedures.

Oh Tae-jeong, Director of the Genomictree Inc. Research Institute, emphasized, “While the essence of this product is to detect cancer, its true purpose lies in reducing unnecessary tests to alleviate the burden on patients and improve the overall efficiency of the healthcare system.”

Genomictree Inc. has also begun developing “EarlyTec-B Plus,” a next-generation product, to address the limitations of its existing product while maintaining its strengths. While the existing EarlyTec-B demonstrates high diagnostic performance for high-grade and invasive bladder cancer, EarlyTec-B Plus also shows high diagnostic performance in detecting early-stage, low-grade, non-muscle-invasive bladder cancer (Ta-LG).

Director Oh elaborated, “Early-stage bladder cancer is one of the most challenging areas to diagnose in clinical practice,” adding, “Although the existing technology already demonstrated excellent performance, we decided to develop an upgraded product to further increase sensitivity to a level where clinicians can use it with even greater confidence.”

To achieve this, the company expanded the analysis scope of the biomarker gene (PENK), which exhibits distinct methylation changes in bladder cancer. By improving the testing method to analyze more methylation sites simultaneously than before, the test can now better detect cancer signals even in early-stage, low-grade bladder cancer. While sensitivity was increased, the high negative predictive value (NPV) was maintained. In other words, if the test result is negative, it is now possible to determine with greater confidence than before that bladder cancer is unlikely to be present.

Next-Generation Strategic Product Targeting U.S. FDA Approval

These characteristics of EarlyTec-B Plus are expected to provide a significant competitive edge, particularly in the U.S. market. In the United States, the American Urological Association (AUA) recently introduced risk-based guidelines for evaluating hematuria and has begun recommending the use of urine-based biomarkers for certain patients with hematuria. This shift demonstrates the rapidly growing clinical demand for non-invasive molecular diagnostics.

Genomictree Inc. has designated EarlyTec-B Plus as the core product in its strategy to secure U.S. Food and Drug Administration (FDA) approval and plans to begin full-scale entry into the global market through future regulatory clinical trials. In particular, since the existing EarlyTec-B has already been designated as a Breakthrough Device by the FDA, EarlyTec-B Plus—developed based on the same biomarkers—is expected to ensure technical and regulatory continuity during the regulatory review process.

In South Korea, the company plans to tap into the non-reimbursed prescription market centered on the existing EarlyTec-B, while in the U.S., it aims to seek FDA approval for EarlyTec-B Plus, which has enhanced performance to cover even early-stage, low-grade bladder cancer.

Director Oh stated, “Rather than conducting clinical trials again in Korea with the Plus version, we are considering pursuing FDA approval first,” adding, “If the FDA recognizes its performance and efficacy, the process of introducing the upgraded product in Korea will be much smoother.” He continued, “EarlyTec-B Plus is a product that organically combines the evolution of clinical performance with regulatory strategy. Based on this, we plan to further accelerate our entry into the global market.”