Chugai Obtains Japanese Approval For FoundationOne Liquid CDx Cancer Genomic Profile As Liquid Biopsy Test For CGP To Treat Solid Tumors

Chugai Pharmaceutical announced that it has obtained approval from the Ministry of Health, Labour and Welfare (MHLW) for FoundationOne Liquid CDx Cancer Genomic Profile as the liquid biopsy (LB) test that provides comprehensive genomic profiling (CGP) for solid tumors. The test was also approved 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.“The approval of FoundationOne Liquid CDx Cancer Genomic Profile, a blood-based CGP option, has a significant meaning for Chugai that aims to advance personalized healthcare based on the genomic profile of a patient’s tumor,” said Chugai’s president and CEO, Dr. Osamu Okuda. “In cancer treatment that continues to evolve day-to-day, it enables us to support a wider range of patients to help inform treatment decisions aligning the patient’s status and stage of treatment by utilizing both tissue-based and blood-based tests. We are committed to preparing for the launch of the test as soon as possible and also will continue to expand companion diagnostic functions with the aim of maximizing the value provided to patients.”Developed by Foundation Medicine Inc. based in Cambridge, USA, FoundationOne Liquid CDx Cancer Genomic Profile is next-generation sequencing based in vitro diagnostic device using blood samples from advanced cancer patients with solid tumors. It identifies genomic alterations in 324 cancer-related genes through detection of blood circulating tumor DNA (ctDNA) in blood. 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 realize advanced personalized healthcare in oncology and contributing to patients and healthcare professionals through improving access to CGP.

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