MEBGEN™ BRAF 3 Kit Receives MHLW Approval and Insurance Coverage as a Tumor Agnostic Companion Diagnostic
JSR Corporation announces that Medical & Biological Laboratories (MBL), a JSR Life Sciences company, announced that the MEBGEN™ BRAF 3 Kit, an in vitro diagnostic reagent, was approved for manufacturing and marketing by the Ministry of Health, Labour and Welfare (MHLW) on August 18, 2023, and received national health insurance coverage on November 1, 2023.
The MEBGEN™ BRAF 3 Kit was developed as a tumor-agnostic companion diagnostic for the detection of BRAF (v-raf murine sarcoma viral oncogene homolog B1) gene mutations (V600E). With MHLW approval and insurance coverage, the MEBGEN™ BRAF 3 Kit is expected to support personalized medicine based on its ability to detect the presence or absence of BRAF gene mutations in rare tumors (solid tumors including histiocytosis and hairy cell leukemia) for which treatment options are limited.
For details, please see the announcement from MBL on URL.