(Health Korea News / Lee Chang-yong) EngeneBio announced on the 20th that it has launched ‘MRDaccuPanel AML FLT3 (‘MRDaccuPanel’)’, an NGS-based ultra-sensitive genetic diagnostic product that helps prescribe targeted anticancer drugs for acute myeloid leukemia (AML), monitor the course of anticancer treatment, and predict cancer recurrence.
‘MLD AccuPanel’ is a product for detecting FLT3 (FMS-like tyrosine kinase 3) gene mutations that determine treatment methods and prognosis in AML patients at a higher resolution than the current level. It consists of a diagnostic kit and analysis software developed based on next generation sequencing (NGS) technology.
Major overseas clinical guidelines, such as the European Leukemia Network (ELN) and the National Comprehensive Cancer Centers Network (NCCN) in the United States, specify FLT3 gene mutation as an important diagnostic and prognostic factor. FLT3 gene mutation is a common genetic alteration in AML patients. It is largely divided into ITD (internal tandem duplication) and TKD (tyrosine kinase domain) mutations. ‘FLT3-ITD’ mutation has been recognized as a representative biomarker of poor prognosis, and ‘FLT3-TKD’ mutation is known as a biomarker showing drug resistance to targeted anticancer drugs.
In order to test for minimal residual disease (MRD), which refers to cancer cells that remain and are not removed during the treatment of various cancers including AML, a diagnostic technology with very high sensitivity and accuracy is required. Currently, first-generation Sanger sequencing or fragment analysis are used to test for FLT3 mutations in clinical practice, but these methods can only test for one type of mutation, either ITD or TKD mutation, or have limitations in the number of mutations that can be tested at one time, and have very low sensitivity for detecting minimal residual disease.
EngeneBio’s ‘MRD AccuPanel’ can detect all ITD and TKD mutations reported so far in the FLT3 gene in a single test. It has a very high level of lower detection limit and sensitivity that can detect minimal residual disease that remains at a rate of one in 100,000 normal blood cells (0.001%). EngeneBio conducted a clinical study with Seoul St. Mary’s Hospital to evaluate the clinical performance of ‘MRD AccuPanel’ and completed performance verification.
CEO Choi said, “Recently, global pharmaceutical companies have been actively utilizing companion diagnostic technologies to develop new targeted anticancer drugs and immune-oncology drugs,” and “EngeneBio is also providing companion diagnostic technologies to effectively select patients suitable for clinical trials of the next-generation FLT3 targeted anticancer drug PHI-101 in cooperation with Pharos I-Bio.”
CEO Choi continued, “We plan to receive approval for the ‘MRD AccuPanel’ that we recently launched as a companion diagnostic medical device for FLT3-targeted anticancer drugs that have already been approved or are currently under development in Korea and abroad.”
Meanwhile, according to statistics from the National Cancer Institute in the United States, the number of new AML cases is expected to exceed 20,000 in 2024. In Korea, 2,666 new AML patients occurred in 2021, according to data from the National Cancer Information Center. Global Information, a global market research institute, forecasted that the FLT3 targeted anticancer drug market will grow at an average annual rate of 15% from USD 470 million (approximately KRW 624.6 billion) in 2023 to USD 1.26 billion (approximately KRW 1.6745 trillion) in 2030. The FLT3 gene mutation diagnosis market for prescribing targeted anticancer drugs is also expected to grow.
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