[Click eStock] "Genomictree, Possible Sales up to 230 Billion KRW in the US"

Hana Securities analyzed on the 10th that Genomictree's early diagnosis of bladder cancer (EolitecB) is expected to generate conservative potential sales of approximately 40 billion to 230 billion KRW annually starting next year, as it begins full-scale entry into the U.S. market.

Choi Jae-ho, a researcher at Hana Securities, stated in a report on the same day, "EolitecB entered the U.S. market through LDT (Laboratory Developed Test) services without FDA approval in June of the same year, after being designated as an innovative medical device by the U.S. FDA in April 2023," adding, "In particular, in April this year, it obtained the CPT-PLA medical code from the American Medical Association (AMA), and on the 3rd of this month, the Medicare and Medicaid Services Center (CMS) set the test price at $192, completing preparations for commercialization."

EolitecB is scheduled to be officially reflected in the AMA CPT codebook effective January 2025, and submission of materials for the MolDx program for Medicare coverage registration is also planned. This is expected to accelerate adoption by insurance companies in the U.S. and secure a competitive advantage in the early diagnosis market for bladder cancer.

He explained, "Approximately 82,000 people are diagnosed with bladder cancer annually in the U.S., and about 10% of diagnosed patients are estimated to be candidates for early testing," estimating that "based on this, more than 820,000 bladder cancer tests are expected to be conducted annually, with EolitecB's potential sales estimated at 40 billion to 230 billion KRW (Korean won basis)."

He added, "Just as New Zealand's Pacific Edge saw a sharp rise in stock price after launching LDT services, Genomictree expects similar growth in the U.S. market," and forecasted, "Currently, Genomictree is the only company providing LDT services for early diagnosis of bladder cancer in the U.S., making it highly likely to secure a monopolistic position in the market."

Furthermore, the early diagnosis product for colorectal cancer, EolitecC, is also in the final stages of preparation for full-scale commercialization. In November, a large-scale confirmatory clinical trial involving 2,358 high-risk patients was completed domestically, and the results report is about to be submitted.

Following this, the company plans to apply for approval from the Ministry of Food and Drug Safety in the first quarter of 2025 and undergo new medical technology evaluation procedures, raising the possibility of inclusion in the national cancer screening program by the end of next year. Since receiving auxiliary diagnostic approval in 2019, EolitecC has been serviced through some hospitals, and from January to October this year, contracts were signed with 98 new hospitals, strengthening its domestic market entry foundation.

He concluded, "Genomictree will achieve substantial sales growth in the U.S. and domestic markets through EolitecB and EolitecC, respectively," and predicted, "Based on competitive technology and market growth potential both domestically and internationally, Genomictree will establish itself as a key player in the early diagnosis market."