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Medical Devices / Submissions and Approvals

Japan Clears Foundation Medicine’s Genomic Profiling Assay

Jan. 4, 2019

Japan’s Ministry of Health, Labor and Welfare has approved Foundation Medicine’s FoundationOne CDx genomic profiling assay.

The sequencing-based assay can detect substitutions, insertion and deletion alterations and copy number alterations in 324 genes, and is able to detect genomic signatures such as the tumor mutations in DNA.

The assay, which received FDA approval in 2017, can also select gene rearrangements that have been found to spur cancer growth.

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