[Click eStock] "Genomictree, EarlyTec BCD US Market Preemption Expected"

On the 5th, KB Securities stated that the US selling price of 'Eolitec BCD,' a bladder cancer diagnostic product by Genomictree, has been set at $192, and it is expected to rapidly penetrate the market.

Han Jeyoon, a researcher at KB Securities, explained, "Eolitec BCD is currently undergoing both confirmatory clinical trials for FDA approval and a Laboratory Developed Test (LDT) service track simultaneously."

He added, "The LDT service track is a system that allows preemptive commercialization if clinical data is favorable, even before FDA approval."

Furthermore, he said, "Eolitec BCD was designated as an innovative medical device by the FDA last year and was even assigned a prescription code," adding, "However, commercialization had been delayed because the selling price had not been finalized." He emphasized, "On the 3rd, Eolitec BCD passed the review procedures of the American Medical Association (AMA) and the Centers for Medicare & Medicaid Services (CMS), receiving final price approval, and it can be supplied at $192 starting next year."

Researcher Han estimated, "Considering that the actual diagnosis rate of bladder cancer in bladder cancer tests is around 10-25%, the annual number of bladder cancer tests will exceed one million." He expected, "Bladder cancer tests involve inserting an endoscope through the urethra, causing significant patient discomfort, so there will be high demand for products that test through urine."

He judged, "Since there are no clear competing products, it can rapidly penetrate the market," adding, "It is a situation where market dominance can be expected." Additionally, he said, "Given the diagnostic kit's characteristics of showing profitability above 40%, a steep increase in profits is expected with market penetration."

This content was produced with the assistance of AI translation services.