FDA approves FoundationOne CDx test as companion diagnostic for several cancer therapies

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Sumary of FDA approves FoundationOne CDx test as companion diagnostic for several cancer therapies:

  • The FDA approved the FoundationOne CDx test as a companion diagnostic device to help identify multiple additional biomarkers in cell-free DNA isolated from plasma, according to a press release from the agency..
  • The approval applies to the use of the next-generation sequencing-based assay to detect BRCA1, BRCA2 and ATM mutations in men with metastatic castration-resistant prostate cancer eligible for treatment with olaparib (Lynparza, AstraZeneca);…

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