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Foundation Medicine receives FDA approval for FoundationOneLiquid CDx as companion diagnostic for metastatic prostate cancer
Precision Medicine
Jul 1, 2024
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Precision Medicine

Precision Medicine

Jul 1, 2024

Foundation Medicine receives FDA approval for FoundationOneLiquid CDx as companion diagnostic for metastatic prostate cancer

FDA approval

  • Foundation Medicine has received FDA clearance for its FoundationOneLiquid CDx, which will be used as a companion diagnostic for Janssen Biotech's AKEEGA in treating BRCA-mutated metastatic castration-resistant prostate cancer.

  • FoundationOneLiquid is a liquid biopsy test that analyzes cancer-related genes to provide genomic insights, including mutations in BRCA1 or BRCA2, useful for treating metastatic castration-resistant prostate cancer. It allows doctors to leverage a minimally invasive liquid biopsy to identify patients with BRCA mutations who may benefit from specific treatments such as AKEEGA and can help make personalized treatments more feasible.

  • Analyst QuickTake: In November 2023 , Foundation Medicine’s FoundationOne CDx tissue-based comprehensive genomic profiling test received FDA approval for use with AstraZeneca's Truqap (capivasertib) and Faslodex (fulvestrant) to treat advanced breast cancer in adults. The test uses a tissue sample to analyze cancer-related genes for genomic alterations in a patient’s tumor.

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