20 March 2018 - - Tokyo, Japan-based pharmaceutical company Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519), a member of the Roche Group, will broaden patient access to Cambridge, Massachusetts-based molecular information company Foundation Medicine, Inc.'s (NASDAQ: FMI) comprehensive genomic profiling (CGP) services for individuals with advanced cancer, FMI said.
Chugai has filed for regulatory approval from the Ministry of Health, Labour and Welfare (MHLW) in Japan for FoundationOne CDx, which, if approved in Japan, would enable access to MHLW-approved targeted therapies and immunotherapies, as well as clinical trials, for patients with cancer in Japan.
Chugai will also lead commercial efforts in Japan for Foundation Medicine's suite of CGP assays. If approved in Japan by the MHLW, Chugai will be the Marketing Authorization Holder of FoundationOne CDx in Japan.
FoundationOne CDx is a next generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability and tumor mutational burden using DNA isolated from formalin-fixed paraffin embedded tumor tissue specimens.
It is intended as a companion diagnostic to identify patients who may benefit from treatment with certain targeted therapies in accordance with their approved therapeutic product labeling, and to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms.
Foundation Medicine offers a full suite of comprehensive genomic profiling assays to identify the molecular alterations in a patient's cancer and match them with relevant targeted therapies, immunotherapies and clinical trials.
Its molecular information platform aims to improve day-to-day care for patients by serving the needs of clinicians, academic researchers, and drug developers to help advance the science of molecular medicine in cancer.
Chugai specializes in prescription pharmaceuticals; it is working to develop innovative products which may satisfy unmet medical needs, mainly focusing on the oncology area.