Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced MHLW approval on May 23, 2024, for FoundationOne®Liquid CDx Cancer Genomic Profile. This approval signifies the inclusion of copy number alterations of cancer-related genes and blood tumor mutational burden (bTMB) score detection in plasma samples, crucial for predicting the efficacy of molecular target therapeutics like immune checkpoint inhibitors. President and CEO, Dr. Osamu Okuda, expressed satisfaction with these additions, emphasizing their significance in aiding cancer treatment decisions, especially for patients where obtaining tissue samples is challenging.
The approval enhances Chugai’s comprehensive genomic profiling (CGP) capabilities, complementing the existing FoundationOne®CDx Cancer Genomic Profile for tissue specimens. These tests facilitate diagnosis and treatment decisions based on regulatory-approved information. Particularly for patients with solid tumors, the use of blood specimens for cancer genome profiling offers valuable insights into the potential effectiveness of anticancer drug treatments, streamlining treatment planning.
Chugai, a leader in oncology, is dedicated to advancing personalized healthcare in oncology, aiming to benefit patients through CGP expansion.
FoundationOne Liquid CDx Cancer Genomic Profile, developed by Foundation Medicine Inc., is a next-generation sequencing-based in vitro diagnostic device utilizing blood samples from advanced cancer patients with solid tumors. It identifies genomic alterations in 324 cancer-related genes and calculates the bTMB score using circulating tumor DNA (ctDNA). The MHLW has approved it as a medical device program with genome profiling and companion diagnostic functions for multiple molecular target drugs.