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FDA approval
Foundation Medicine receives FDA approval for FoundationOne CDx
Precision Medicine
Nov 20, 2023
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Precision Medicine

Precision Medicine

Nov 20, 2023

Foundation Medicine receives FDA approval for FoundationOne CDx

FDA approval

  • CDx tools provider Foundation Medicine has received FDA approval for FoundationOne CDx, a diagnostic intended for use with AstraZeneca's Truqap (capivasertib) and Faslodex (fulvestrant) to treat advanced breast cancer in adults.

  • FoundationOne CDx is a next-generation sequencing-based diagnostic device reportedly capable of analyzing over 300 cancer-related genes for genomic alterations in a patient’s tumor. The test has more than 35 companion diagnostic indications, out of which five are related to breast cancer.

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