NGeneBio launches ultra-sensitive gene panel for AML treatment and monitoring

NGeneBio, a Korean precision diagnostics platform company, said it launched MRDaccuPanel AML FLT3, an NGS-based ultra-sensitive gene diagnostics product to assist in the prescription of targeted therapies, monitor treatment, and predict relapse in acute myeloid leukemia (AML) patients.

The MRDaccuPanel detects mutations in the FLT3 (FMS-like tyrosine kinase 3) gene, a key biomarker that influences treatment decisions and prognosis for AML patients.

This product utilizes next-generation sequencing (NGS) technology, surpassing current detection methods in sensitivity and resolution. The diagnostics kit is accompanied by analysis software to ensure accurate identification of FLT3 mutations.

Key clinical guidelines, such as those from the European Leukemia Network (ELN) and the National Comprehensive Cancer Network (NCCN), recognize FLT3 mutations as important indicators for AML diagnosis and prognosis.

FLT3 mutations are commonly seen in AML patients and are classified into two major categories --internal tandem duplication (ITD) and tyrosine kinase domain (TKD) mutations.

FLT3-ITD mutations are particularly associated with poor prognosis as FLT3-TKD mutations are known to show resistance to targeted therapies.

AML and other cancer treatments often require high-sensitivity diagnostics to detect minimal residual disease (MRD)—the small number of cancer cells that remain after treatment and can cause relapse.

However, current clinical methods, including Sanger sequencing and fragment analysis, have limitations in sensitivity and the ability to detect multiple mutations simultaneously.

MRDaccuPanel offers comprehensive detection of all reported ITD and TKD mutations in FLT3 with a single test and can identify MRD at levels as low as 0.001 percent, detecting one cancer cell among 100,000 healthy cells.

NGeneBio has successfully validated the panel's clinical performance through collaborative research with Seoul St. Mary's Hospital.

“Global pharmaceutical companies are increasingly integrating companion diagnostics into the development of new targeted and immunotherapies,” NGeneBio CEO Choi Dae-chul said. “NGeneBio, in partnership with Pharos iBio, is also providing companion diagnostics for patient selection in clinical trials for the next-generation FLT3-targeted therapy PHI-101.”

The company plans to seek regulatory approval for MRDaccuPanel as a companion diagnostic for both approved and pipeline FLT3-targeted therapies in local and international markets, Choi added.

According to the U.S. National Cancer Institute, over 20,000 new cases of AML are expected in the U.S. in 2024. In Korea, 2,666 new cases were reported in 2021, based on data from the National Cancer Information Center.

Global Information, a market research firm, projects the FLT3-targeted therapy market to grow from $470 million in 2023 to $1.26 billion by 2030, with an annual growth rate of 15 percent.