Genomictree (CEO Seonghwan Ahn) announced on the 7th that it has successfully completed the confirmatory clinical performance trial (NEXT-CRC) for the manufacturing approval of the in vitro molecular diagnostic product for early detection of colorectal cancer, 'Eolitec-C,' from the Korea Food and Drug Administration.
The main purpose of this clinical trial was to evaluate the diagnostic performance of 'Eolitec-C' for colorectal cancer in high-risk groups, conducted prospectively and in a blinded manner across multiple centers (15 university hospitals nationwide).
The trial subjects were 2,358 high-risk patients aged 40 or older scheduled for colonoscopy. Stool samples were collected before the colonoscopy and tested with 'Eolitec-C.' The results were evaluated by comparing them to the standard reference of colonoscopy and histopathological readings. Additionally, a direct comparative test with the existing fecal immunochemical test (FIT) was conducted on the same patient group. Analysis of the confirmatory clinical performance trial data demonstrated that 'Eolitec-C' statistically met the diagnostic performance targets set as the primary objective, and showed superior sensitivity compared to the existing fecal immunochemical test.
'Eolitec-C' is an in vitro molecular diagnostic product developed by Genomictree that uses methylation of the ‘Syndecan-2 (SDC2)’ gene, discovered independently by the company, as a biomarker. It diagnoses colorectal cancer by sensitively measuring small amounts of the biomarker in stool through an innovative PCR-based measurement method called LTE-qMSP. 'Eolitec-C' has already been approved by the Korea Food and Drug Administration and is used as a colorectal cancer diagnostic tool in some health screening services.
Dr. Taejung Oh, Head of Research and Development at Genomictree, stated, “Through this clinical trial, we were able to demonstrate the diagnostic performance of 'Eolitec-C' in high-risk colorectal cancer groups, and we expect that cost reimbursement for diagnosis in these patient groups will become more reasonable in the future.” He added, “We plan to continuously strengthen the necessary evidence to facilitate smooth insurance listing.”
Meanwhile, Genomictree plans to promptly prepare the final clinical trial report and proceed with the manufacturing approval application to the Korea Food and Drug Administration.
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