Chugai Gets Japanese Approval for Foundationone Liquid CDx Cancer Genomic Profile

Chugai Gets Japanese Approval for Foundationone Liquid CDx Cancer Genomic Profile

By, Admin 29 May 2024

Chugai gets Japanese approval for FoundationOne Liquid CDx Cancer Genomic Profile to provide information on detection of copy number alterations of cancer-related genes and bTMB score

Overview

Chugai Pharmaceutical Co., Ltd. announced that it has obtained approval from the Ministry of Health, Labour and Welfare (MHLW) on May 23, 2024, for FoundationOne Liquid CDx Cancer Genomic Profile to provide information on detection of copy number alterations of cancer-related genes and blood tumour mutational burden (bTMB) score. Copy number alterations and bTMB score in plasma samples are important indicators for predicting the efficacy of molecular target therapeutics such as immune checkpoint inhibitors. With this approval, our two comprehensive genomic profiling (CGP) tests using tissue and blood specimens, including FoundationOne CDx Cancer Genomic Profile, can support diagnosis and treatment decisions based on regulatory-approved information.

Words from CEO: Chugai

  • “We are pleased that two important additions that support cancer treatment decisions have been approved for FoundationOne Liquid CDx Cancer Genome Profile based on blood specimens in addition to the FoundationOne CDx cancer genomic profile using tissue specimens,” said Chugai’s president and CEO, Dr. Osamu Okuda. 
  • “For patients with solid tumours for whom it is difficult to collect tissue samples, cancer genome profiling tests using blood specimens provide information on predicting the effectiveness of anticancer drug treatment, allowing for smooth consideration of treatment plans. We will continue our efforts to realize advanced personalized healthcare.”

About Chugai

As a leading company in the field of oncology, Chugai is committed to realizing advanced personalized healthcare in oncology and contributing to patients through the expansion of CGP.

FoundationOne Liquid CDx Cancer Genomic Profile

  • Developed by Foundation Medicine Inc. based in Boston, 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 tumours. 
  • By using circulating tumour DNA (ctDNA) in the blood of patients with advanced solid tumours, it is intended to identify genomic alterations (base substitutions, insertions/deletions, rearrangements, copy numbers alterations) in 324 cancer-related genes and calculate the bTMB score. 
  • It has been approved by the MHLW as a medical device program that has a genome profiling function for cancer-related genes and a companion diagnostic function for multiple molecular target drugs.

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