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Foundation Medicine CDx Gains Japanese Approval to Detect Copy Number Alteration, bTMB Score

NEW YORK – Chugai Pharmaceutical announced Monday that Japan's Ministry of Health, Labour, and Welfare has approved the FoundationOne Liquid CDx Cancer Genomic Profile to provide information on the detection copy number alterations and the blood tumor mutational burden (bTMB) score. 

Copy number alterations in cancer-related genes and the bTMB score can be indicators to predict the efficacy of molecular target therapeutics, such as immune checkpoint inhibitors, Chugai said in a statement. 

Roche subsidiary Foundation Medicine developed the FoundationOne test while Chugai is the marketing authorization holder of the assay in Japan. 

"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," Chugai President and CEO Osamu Okuda said in a statement. "For patients with solid tumors 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." 

The test is a next-generation sequencing-based assay that uses circulating tumor DNA in plasma samples to identify genomic alterations in 324 cancer-related genes and calculate the bTMB score.