Genomictree announced that its urine-based bladder cancer molecular diagnostic test, 'EarlyTect-B,' has received conditional approval for a new health technology assessment. Following this approval, EarlyTect-B will be available for non-covered prescription at domestic medical institutions starting in August. Genomictree plans to use this as a springboard to aggressively target the domestic bladder cancer diagnostic market.

[Non-Invasive Test to Address Gaps in Hematuria Patient Care] EarlyTect-B is a non-invasive molecular diagnostic test that analyzes DNA methylation of the PENK gene, a bladder cancer biomarker, using urine. Traditionally, in bladder cancer clinical settings, even when gross or microscopic hematuria is identified, it often does not immediately lead to a cystoscopy. In particular, primary care institutions have had limited non-invasive testing options to objectively evaluate patients with microscopic hematuria. As a result, many cases relied on simple observation or referral to higher-level hospitals, leading to continued demand in clinical settings for evidence-based non-invasive tests to address this issue. Genomictree expects EarlyTect-B to establish itself as a new testing option that bridges this gap in patient care.

[Clinical Evidence Published in JAMA Oncology and Included in AUA Guidelines] The confirmatory clinical results of the test were published in the international academic journal 'JAMA Oncology,' demonstrating high clinical utility. Notably, for high-grade or invasive bladder cancers that must be clinically detected, a sensitivity of 89.2% and a negative predictive value of 97.6% were confirmed. This clinical evidence has been included in the American Urological Association (AUA) guidelines and is currently utilized as a basis for clinical practice.

[Establishment of Distribution Network Covering Approximately 4,000 Medical Institutions Nationwide and Three-Phase Commercialization] While independently pursuing sales and marketing centered on secondary and tertiary hospitals, Genomictree has also signed a partnership agreement with Korea's largest reference laboratory to ensure rapid nationwide market expansion from the initial launch. Through this, the company has established a testing and distribution system leveraging approximately 300 professional sales personnel and a network of around 4,000 medical institutions nationwide. By operating based on a nationwide infrastructure—from sample transportation to test execution and result reporting—the company can provide the same high-quality testing services anywhere in the country from the initial launch without the need to build a separate logistics network.

• Simultaneously with the product launch, the company plans to distribute clinical data and prescription guidelines to medical professionals and expand the market with a focus on internal medicine, nephrology, and urology departments. The company's commercialization strategy will be carried out in the following three phases:
• Phase 1 (August~): Expand non-covered prescriptions primarily at primary care institutions.
• Phase 2 (Q4): Sequentially complete the registration of hospital test codes at general hospitals and expand prescriptions to secondary and tertiary hospitals.
• Phase 3 (Year-end~Next Year): Promote the introduction of the test into health checkup programs and begin generating full-scale revenue through health screening centers starting next year.

Ahn Sung-hwan, CEO of Genomictree, stated, "While EarlyTect-C was a product that pioneered the domestic non-invasive molecular diagnostics market and accumulated clinical evidence and commercialization experience, EarlyTect-B is the first product to be launched fully equipped with new health technology strategies, clinical evidence, a nationwide sales network, and testing infrastructure based on those experiences." He added, "Having already established a nationwide testing and supply system, we aim to lead the domestic bladder cancer diagnostic market through rapid market adoption and expansion across medical institutions."