- FoundationOne Liquid CDx Cancer Genomic Profile is now available for use as a comprehensive genomic profiling test covering 324 genes as well as a companion diagnostic to identify patients who may benefit from certain approved targeted therapies across multiple cancer indications
TOKYO, August 2, 2021 – Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced today that it has launched FoundationOne® Liquid CDx Cancer Genomic Profile as a liquid biopsy-based comprehensive genomic profiling (CGP) test for solid tumor, following the product’s listing on the national health insurance (NHI) reimbursement price list on August 1, 2021. In addition, SRL Inc., the clinical laboratory testing company has started providing testing services for the product today. FoundationOne Liquid CDx Cancer Genomic Profile was approved by the Ministry of Health, Labour and Welfare (MHLW) on March 22, 2021 for use as a companion diagnostic (CDx) for certain approved targeted therapies in Japan, making it the first MHLW-approved blood-based test with both CDx and solid tumor CGP indications.
“We are very pleased that we can start providing FoundationOne Liquid CDx Cancer Genomic Profile, a blood-based CGP testing option for patients today. The test provides meaningful information that can help inform treatment for patients with advanced or recurrent cancer, which is especially valuable if they are not eligible for tissue-based CGP testing,” said Chugai’s president and CEO Dr. Osamu Okuda. “We are committed to advance personalized healthcare through expanding access to CGP testing.”
Developed by Foundation Medicine Inc. based in Cambridge, USA, FoundationOne Liquid CDx Cancer Genomic Profile is a blood-based diagnostic test that uses next-generation sequencing. It identifies genomic alterations in 324 cancer-related genes for cancer patients with solid tumors through detection of blood circulating tumor DNA (ctDNA). FoundationOne Liquid CDx Cancer Genomic Profile provides an integrated test report informing alterations matched to MHLW-approved targeted therapies.
As a leading company in the field of oncology, Chugai is committed to advance personalized healthcare in oncology and contributing to patients and healthcare professionals through improving access to CGP.
|Brand name||FoundationOne® Liquid CDx Cancer Genomic Profile|
|Japanese medical device nomenclature (JMDN)||
|Intended uses or indications||
|Conditions for approval||
|Date of NHI reimbursement price listing:||August 1, 2021|
About FoundationOne Liquid CDx Cancer Genomic Profile
Developed by Foundation Medicine Inc. based in Cambridge, USA, FoundationOne Liquid CDx Cancer Genomic Profile is a next-generation sequencing based in vitro diagnostic device using blood samples for advanced cancer patients with solid tumors. It is intended to identify genomic alterations in 324 cancer-related genes through detection of blood circulating tumor DNA (ctDNA). The test is approved by the MHLW for use in cancer genome profiling to report substitutions, insertion and deletion alterations, and select gene rearrangements for short variants in 324 genes. It is also indicated for use as a companion diagnostic to identify patients who may benefit from treatment with specific targeted therapies (listed in Table above of Intended uses or indications). For the latest information about the product, including companion diagnostic indications, please refer to the prescribing information.
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