NGeneBio said on Monday that it signed a technology transfer contract with The Catholic University of Korea Industry-Academic Cooperation Foundation and Dow Biomedica to commercialize a product that can check the variation of minimal residual disease (MRD).

Acute myeloid leukemia (AML) is fast-growing cancer whereby myeloblasts rapidly multiply in the bone marrow and blood but can spread to other regions if not quickly treated. As the prognosis is poor, it is important to lower the risk of recurrence. The main cause of this recurrence is MRD whereby cancer cells that might have not been detected during leukemia treatment remain in very small amounts, causing a relapse.

In AML patients, the FMS-like tyrosine kinase 3 (FLT3) mutation is the most common and the FLT3-internal tandem duplication (ITD) mutation is a representative biomarker of MRD due to poor prognosis.

However, the existing FLT3-ITD mutation test method has low sensitivity, making it difficult to detect MRD. Previous research can measure the FLT3-ITD variation by 0.001 percent or less by applying next-generation sequencing (NGS) technology, but there are no commercial products yet.

The NGS-based AML test product, called MRDaccuPanel AML FLT3-ITD, will be able to detect ITDs of FLT3 genes of lengths that could not be detected through conventional methods with higher sensitivity and accuracy than other platforms. 

Additionally, variations in the tyrosine kinase domain (TKD) region can be confirmed and it can simultaneously test and diagnose MRD and drug resistance, and predict prognosis in AML patients.

“It has become important to identify remaining cancer cells through MRD tests after cancer treatment,” NGeneBio CEO Choi Dae-chul said, "We will commercialize a precise blood cancer diagnostic test that can monitor biomarkers for minimal residual disease using the sensitive NGS diagnostic to help AML patients.”