ALISO VIEJO, Calif.--(BUSINESS WIRE)--REALM IDx, Inc., a health care company pioneering the field of integrated diagnostics, announced today that GenMineTOP Cancer Genome Profiling System (“the System”) has been awarded national health coverage in Japan and will begin full commercial launch of contract testing with strategic partner, LSI Medicine Corporation (Chiyoda-ku, Tokyo; hereinafter “LSIM”).
Developed in a collaboration that began in 2019 between the University of Tokyo, the National Cancer Center Research Institute, and REALM’s operating team in Japan, the PMDA approved System utilizes next-generation sequencing to perform simultaneous analysis of DNA and RNA from paired tumor tissue specimen and non-tumor blood specimen to deliver broad detection of gene variants related to cancer. The comprehensive panel includes variant analysis of 737 cancer-related genes, including base substitutions, insertion/deletions and copy number aberrations, and RNA gene fusion detection in 455 genes, exon-skipping detection in 5 cancer-related genes, and expression profiling of 27 cancer-related genes. Japan’s Ministry of Health, Labour and Welfare approved use of the System for the diagnosis of solid tumor patients and to aid in determining the course of treatment.
“Our collaboration brought together the best of academia and industry, and will have a tremendous impact on empowering clinical decision-making and improving patient outcomes. Through our NCC TOP-GEAR 5th: Pediatric/Adolescent and Young Adult (AYA) Cancers project, our interim results demonstrated that actionable clinical benefit was identified via GenMineTOP for an additional 20% of patients,” said Dr. Kayoko Tao, Department of Pediatric Oncology, National Cancer Center Japan. “We are thrilled that the PMDA approval and national health coverage of the system will support greater access to health care providers and cancer patients in Japan.”
In the United States and global regions outside of Japan, the company will offer a research-use version of GenMineTOP for clinical research and the investigation of new targeted therapies for cancer treatment. It will be offered through REALM Pharma Services, the company’s recently launched end-to-end discovery, translational research, and clinical trial service for biotechnology and pharmaceutical partners.
“GenMineTOP cancer genome profiling system is an important addition to the REALM Pharma Services offering and further strengthens our work in integrated diagnostics,” said Aaron Elliott, PhD, Chief Executive Officer of REALM IDx. “Our capabilities are unique in the industry as it encompasses world-class genomics, spanning germline and somatic analysis, expression analysis, pathology, spatial imaging and advanced analytics. This enables a transformative shift in research and new, data-driven insights for precision medicine.”
About REALM IDx
REALM IDx, Inc. is a health care company pioneering in the field of Integrated Diagnostics (IDx), an advanced field of clinical science that brings together laboratory medicine, radiology, pathology and sophisticated artificial intelligence to derive actionable insights to predict, diagnose and treat disease. Powered by proprietary software platforms, industry-leading genomics technology from Ambry Genetics Corporation and radiology and pathology services from Invicro, LLC, the company is equipped to collect, analyze and report on multi-modal precision diagnostic data sets. REALM's extensive network of healthcare providers and pharmaceutical partners will drive clinical access to innovations that lead to better medical solutions for patient care. For more information, visit REALMIDx.COM, or connect on Twitter, LinkedIn and Facebook.
