NEW YORK — Realm IDx said on Tuesday that its GenMineTOP Cancer Genome Profiling System test has received national health coverage in Japan.
Following the receipt of coverage, commercial rollout of the test in Japan will begin with strategic partner LSI Medicine, Realm IDx said. The test will be made available in the US and other regions outside of Japan for research use only through the company's recently established Realm Pharma Services service.
According to Aliso Viejo, California-based Realm ID, the test uses next-generation sequencing to simultaneously analyze DNA and RNA from paired tumor tissue specimens and non-tumor blood specimens in order to detect cancer-related gene variants and guide treatment decisions.
Developed by Realm IDx in collaboration with the University of Tokyo and Japan's National Cancer Center Research Institute, the assay analyzes variants in 737 cancer-related genes, including base substitutions, insertion/deletions, and copy number aberrations. It also detects RNA gene fusions in 455 genes and exon skipping in five genes, and profiles the expression of 27 genes.
The test has been approved by Japan's Ministry of Health, Labor, and Welfare for the diagnosis of solid tumor patients and to aid in determining the course of treatment, according to Realm IDx, formerly known as Konica Minolta Precision Medicine.