NGeneBio Clinically Validates Leukemia MRD Detection Technology; Study Published in International Journal

Analysis with Seoul St. Mary's Hospital of 115 AML patients and 353 bone marrow samples
FLT3-ITD-positive detection rate: 60.1%
3.5 times higher than with conventional testing methods

NGeneBio said on November 13 that the results of a performance evaluation study on its leukemia measurable residual disease (MRD) detection technology, conducted jointly with Seoul St. Mary's Hospital, were published in the international journal Annals of Laboratory Medicine.

MRD AccuPanel AML FLT3 product image. NGeneBio

The study analyzed 353 bone marrow samples collected from 115 patients with FLT3-ITD-positive acute myeloid leukemia (AML). The researchers evaluated the analytical and clinical performance of NGeneBio's next-generation sequencing (NGS)-based precision diagnostic panel, MRD AccuPanel, and its analysis software, NGeneAnalysis.

The study found that MRD AccuPanel had a 95% limit of detection of approximately 0.0011% based on variant allele frequency (VAF). Its FLT3-ITD-positive detection rate was 60.1%, about 3.5 times higher than that of the conventional testing method (17.2%). In samples collected at complete remission before hematopoietic stem cell transplantation, the positive detection rate was 65.3%, about 4.5 times higher than the rate for the conventional method (14.5%).

The study also confirmed the potential to distinguish coexisting mutant clones in the same patient and track low-frequency mutations. Minor clones were found in about 40% of the 115 patients at initial diagnosis, and analysis of samples collected before and after treatment showed changes in mutant clones in some patients.

NGeneBio said the study was significant because it confirmed the performance of its ultrasensitive FLT3-ITD detection technology using clinical samples. The company recently completed the registration of a domestic patent for FLT3-ITD Score, an algorithm designed to improve the accuracy of FLT3-ITD variant detection. In its own performance evaluation, the algorithm eliminated 94.5% of false-positive variants.

NGeneBio plans to use the study results to support commercialization, including obtaining regulatory approvals overseas and expanding supply to global medical institutions.

Lee Jongmi, a professor in the Department of Laboratory Medicine at Seoul St. Mary's Hospital, said, "We confirmed that it is possible to track trace amounts of residual FLT3-ITD mutations that are difficult to detect with conventional testing methods, as well as mutant clones that change during treatment."

Lee Geunsuk, head of NGeneBio's Corporate Research Institute and chief technology officer (CTO), said, "Based on the results of this study, we will pursue regulatory approvals overseas and expand supply to global medical institutions."

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