NGeneBio Secures Patent for 'FLT3-ITD' Mutation Detection to Track AML Relapse

Algorithm to Be Applied to New Blood Cancer Panel in Q1 Next Year

NGeneBio has secured a domestic patent for a precision diagnostic technology that tracks the risk of relapse in patients with acute myeloid leukemia (AML).

NGeneBio CI. NGeneBio

On November 5, NGeneBio announced that it had obtained a domestic patent for a next-generation sequencing (NGS)-based method for detecting FLT3-ITD mutations. Its proprietary FLT3-ITD Score algorithm revalidates mutation candidates identified by existing analysis software. It assesses five factors—the number and frequency of mutation observations, sequencing depth, mutation length, and sequence concordance—to identify only true mutations.

In performance evaluations, the algorithm eliminated 94.5% of "false-positive mutations" that existing software had incorrectly classified as blood cancer mutations. It also filtered out an additional 79.7% of false-positive mutations that remained after standard filtering.

FLT3-ITD is a key genetic mutation used to assess prognosis and relapse risk in patients with AML. In minimal residual disease (MRD) testing, which detects trace amounts of cancer cells remaining in the body after treatment, the challenge is to detect even very small quantities of mutations while minimizing errors. However, accurately identifying FLT3-ITD mutations has been difficult because their lengths and locations vary, and results can differ depending on the analysis software used.

The patented technology has already been incorporated into NGeneBio's MRD diagnostic panel, MRD AccuPanel AML FLT3, and its analysis software, NGeneAnalysis. The company plans to apply the algorithm to its HEME Panel for blood cancer diagnosis, which is under development with a target launch in the first quarter of 2027. The HEME Panel, which will be launched for research use, is being developed to reduce the test preparation process from about two days to about seven hours.

Lee Gyeongnam, CEO of NGeneBio, said, "Securing a series of patents is the result of our efforts to develop key analytical technologies for precision diagnosis of blood cancers in-house. We will extend our proprietary algorithm, already used in commercial products, to new diagnostic products and deliver results in overseas markets as well."

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