[E-Daily Reporter NA EUN-KYUNG ] EarlyTect-B ( Genomictree Inc.(228760)) announced on the 14th that its urine-based molecular diagnostic test for bladder cancer, “EarlyTect-B,” has received deferred approval under the New Medical Technology Evaluation system.

With this approval, EarlyTect-B will be available for non-insured prescription at domestic medical institutions starting this August. The company plans to use this as an opportunity to expand its testing services to medical institutions nationwide and target the domestic bladder cancer diagnostic market.

EarlyTect-B is a non-invasive molecular diagnostic test that analyzes DNA methylation of the PENK gene—a bladder cancer biomarker—in urine. Clinical results were published in *JAMA Oncology*, the official journal of the American Society of Clinical Oncology (ASCO), and the test demonstrated sensitivities of 89.2% and 97.6% in patients with low-grade and high-grade non-muscle-invasive bladder cancer, respectively. This clinical evidence has been incorporated into the American Urological Association (AUA) guidelines and is being used as a basis for clinical practice.

The company expects EarlyTec-B to address unmet needs in the diagnosis and treatment of bladder cancer. Given the limited availability of non-invasive tests that can objectively evaluate patients with hematuria before they undergo cystoscopy, the company believes the test will serve as a new diagnostic option in clinical practice.

The company has also established a testing infrastructure to expand its market reach. In collaboration with South Korea’s largest clinical laboratory, the company has set up a testing and distribution system connecting approximately 4,000 medical institutions nationwide. Leveraging a team of about 900 specialized sales representatives and its nationwide testing network, the company plans to provide consistent service—from test order placement to execution and result reporting—anywhere in the country. Clinical data and prescribing guidelines for healthcare professionals will also be distributed upon the product’s launch.

According to the company, commercialization will proceed in phases. First, starting in August, the company plans to expand non-reimbursed prescriptions, focusing on primary care facilities. In the fourth quarter, it plans to expand supply to secondary and tertiary care facilities after registering the test code with general hospitals. Subsequently, the company aims to promote the adoption of the test into health screening programs by the end of the year, with the strategy to fully ramp up sales through health screening centers starting in 2027.

Ahn Seong-hwan, CEO of Genomictree Inc., stated, “While EarlyTec-C was a product that pioneered the domestic non-invasive molecular diagnostics market and accumulated clinical evidence and commercialization experience, EarlyTec-B is a product being launched based on that experience—already equipped with a waiver from the New Medical Technology Assessment, clinical evidence, a nationwide sales network, and testing infrastructure.” He added, “We will lead the domestic bladder cancer diagnostics market through rapid market penetration and expansion into medical institutions.”