Genomictree's 'Eolitec-B' Clinical Results Published in Prestigious Journal 'JAMA Oncology'

Genomictree announced on the 31st that the clinical trial results for manufacturing approval by the Korean Ministry of Food and Drug Safety of ‘EarlyTec-B,’ an extracellular molecular diagnostic method for bladder cancer developed by the company, have been published in ‘JAMA Oncology,’ a prestigious academic journal published by the American Medical Association.

This study is the first case to internationally recognize the innovation of bladder cancer diagnosis conducted in Korea. The clinical trial was conducted prospectively on 1,099 patients with hematuria at 10 university hospitals in Korea, including Seoul Asan Medical Center and Seoul National University Hospital.

The research team collected urine samples from hematuria patients scheduled for cystoscopy and performed the ‘EarlyTec-B’ test, then compared and analyzed the results with the standard cystoscopy and histopathological diagnosis. The primary objective of this clinical trial was to evaluate the performance in diagnosing ‘high-grade or invasive bladder cancer,’ which carries a risk of disease progression.

As a result, the sensitivity was 89.2%, negative predictive value was 97.7%, and specificity was 87.8%, demonstrating superior sensitivity compared to the previously approved products ‘NMP22 test (51.5%)’ and ‘urine cytology test (39.7%).’ These results were published in ‘JAMA Oncology,’ objectively recognizing the high potential for early diagnosis of bladder cancer, and the same clinical trial data were submitted for manufacturing approval to the Korean Ministry of Food and Drug Safety.

In particular, ‘EarlyTec-B’ was recognized for its innovation in more accurately diagnosing bladder cancer and was designated as a ‘Breakthrough Device’ by the U.S. FDA in April 2023, and in March 2024, it was also designated as an innovative medical device by the Korean Ministry of Food and Drug Safety.

Professor In-Gap Jeong of the Department of Urology at Seoul Asan Medical Center and Professor Cheol Kwak of Seoul National University Hospital, the lead authors of this study, emphasized, “Early detection of high-grade or invasive bladder cancer allows for prompt treatment, which can save patients’ lives and significantly reduce the risk of death from cancer.” They added, “This test is very useful in reducing unnecessary cystoscopies and helping only those patients who truly need it to receive accurate testing.”

Genomictree CEO Seong-Hwan Ahn stated, “Through this clinical trial, the ‘EarlyTec-B’ test demonstrated outstanding performance surpassing existing approved in vitro diagnostic products and showed that it can be effectively used for early diagnosis of bladder cancer.” He added, “It also has the potential to be used as a monitoring tool for bladder cancer recurrence in the future, which is expected to contribute greatly not only clinically but also economically.”

Meanwhile, ‘JAMA Oncology,’ where the paper was published, is one of the most prestigious journals in the field of oncology research. As of 2024, it boasts an impact factor of 22.3, reflecting high credibility in the global academic community. ‘JAMA Oncology’ ranks within the top 5% in the field of oncology research, serving as a measure of research reliability and international influence, and studies published in this journal are recognized as important indicators of outstanding research achievements and academic contributions.