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Jun 03, 2019
Chugai Launches Genomic Mutation Analysis Program, FoundationOne CDx Cancer Genomic Profile
TOKYO, June 3, 2019 -- Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced today that it has launched FoundationOne® CDx Cancer Genomic Profile, (hereafter “the Program”) a next-generation sequencing based gene mutation analysis program. Also, SRL Inc. has started providing testing services for the Program today.
FoundationOne CDx is the first cancer genomic test in Japan which obtained regulatory approval for the two functions of gene mutation analysis program (for use in cancer genome profiling) for solid tumors, and somatic gene mutation analysis program (for use in assessing anticancer drug indications). The approval was granted by the Ministry of Health, Labour and Welfare on December 27, 2018.
“FoundationOne CDx Cancer Genomic Profile will open up a new horizon for personalized cancer care. I am delighted that the program is now available for patients and healthcare providers in Japan,” said Tatsuro Kosaka, Chugai’s President and CEO. “Through this program, Chugai will further strive to realize advanced and sustainable patient-centric healthcare by promoting access to treatments optimized to each patient.”
Developed by Foundation Medicine Inc., FoundationOne CDx Cancer Genomic Profile is a next-generation sequencing based in vitro diagnostic device for the detection and analysis of substitutions, insertion and deletion alterations, and copy number alterations in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from patient’s tumor tissues. As a comprehensive companion diagnostic function, it can be also used as a companion diagnostic for certain molecular-targeted drugs approved in Japan.
As a leading company in the field of oncology, Chugai is committed to realize advanced personalized oncology care and contribute to patients and healthcare providers through comprehensive genomic profiling.
[Notes]
A press release issued on March 19, 2019: Miraca and Chugai Enter into Business Partnership Agreement for “FoundationOne® CDx Cancer Genome Profile”
https://www.chugai-pharm.co.jp/english/news/detail/20190319150000_603.html
Approval information
Brand name | FoundationOne® CDx Cancer Genomic Profile | |||||||||||||||||||
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Approval date | December 27, 2018 | |||||||||||||||||||
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Conditions for approval |
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Trademarks used or mentioned in this release are protected by laws.
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