[Edaily Reporter NA EUN-KYUNG ] Genomictree Inc.(228760)has begun preparations for commercialization by hosting a symposium for urology practitioners to introduce the clinical performance and practical applications of its bladder cancer in vitro diagnostic test, “EarlyTect-B.” The company announced that it is currently undergoing the New Medical Technology Evaluation deferral process and plans to enter the non-reimbursed market as early as this August.

Genomictree Inc. held the “EarlyTect-B Clinical Performance Results Sharing Conference” (Clinical Insights: Sharing Clinical Performance of EarlyTect-B) on the evening of the 23rd at the Westin Parnas Hotel in Seoul. Professor Kwak Cheol of Seoul National University Hospital served as the moderator for the event, and Professor Seong Hyun-hwan of Samsung Seoul Hospital delivered a presentation on “The Clinical Utility of EarlyTect-B.”

EarlyTect-B is a bladder cancer in vitro diagnostic test commercialized by Genomictree Inc. that assesses the likelihood of cancer by measuring bladder cancer-related DNA methylation biomarkers in urine. It was developed to address the invasiveness of conventional cystoscopy and the low sensitivity of urinary cytology, and received marketing authorization from the Ministry of Food and Drug Safety last January.

In his presentation that day, Professor Seong explained that EarlyTec-B demonstrated high sensitivity and specificity in a multicenter, prospective clinical trial involving patients with hematuria. He noted that the study, led by the Korean Society of Urological Oncology and conducted at 10 institutions nationwide, included a total of 1,099 participants, and that in analyses targeting high-risk bladder cancer, both sensitivity and specificity approached 90%.

In particular, Professor Seong emphasized the negative predictive value (NPV). He stated, “If this test yields a negative result, it can be interpreted that 97.6% of patients do not have cancer,” adding, “It demonstrates exceptional performance as a screening test for patients with hematuria.”

He also explained that the test demonstrated superior results in terms of sensitivity when compared to existing bladder cancer screening methods, such as the NMP22 assay and urine cytology. Professor Seong remarked, “While specificity was similar, sensitivity was significantly higher than that of the NMP22 assay and urine cytology,” adding, “It is highly valuable for use in the patient screening process.”

Professor Seong also noted that EarlyTec-B has already been included in the American Urological Association (AUA) guidelines. He said, “It is highly significant that a bladder cancer diagnostic test developed in Korea has been incorporated into international guidelines,” adding, “It can serve as an adjunct diagnostic tool during the waiting period for university hospital appointments or help provide objective evidence during patient consultations.”

In the subsequent session, representatives from Genomictree Inc. presented the product’s usage instructions and commercialization plans. According to the company, EarlyTec-B requires only a urine sample for testing, and collected samples can be stored at room temperature for up to one month. Test results are typically available within 5 to 7 days on average and are delivered to medical institutions within a maximum of two weeks.

The company is currently undergoing the New Medical Technology Evaluation deferral process and plans to launch full-scale testing services after receiving approval for non-insured coverage. Hong Ye-seul, an associate at Genomictree Inc., said during the Q&A session, “We expect to receive approval for the deferral of the New Medical Technology Evaluation in early August,” adding, “We have completed preparations to launch the testing service immediately upon approval.” The company anticipates that the actual out-of-pocket cost for patients will be in the low to mid-100,000 won range, depending on pricing set by individual medical institutions.

A urologist in private practice who attended the event remarked, “This test appears to be useful for patients who continue to experience hematuria even after treatment for cystitis, or for those who require an evaluation of the underlying cause.”