U.S. Food and Drug Administration (FDA) has approved the FoundationOne CDx as a companion diagnostic to guide treatment selection for patients with non-small cell lung cancer. This approval applies to the use of FoundationOne CDx (Foundation Medicine) to identify NSCLC patients whose tumors have EGFR exon 19 deletions or exon 21 L858R alterations and are appropriate for treatment with FDA-approved EGFR tyrosine kinase inhibitors. This CDx is an in vitro diagnostic device and it is designed to detect substitutions, insertion and deletion alterations. The FDA approval works as a companion diagnostic to guide treatment selection for certain non-small cell lung cancer patients.
This approval is the first FDA-approved tissue-based broad companion diagnostic and the test results help to inform immunotherapy decisions. EGFR mutations are the second most common oncogenic drivers in NSCLC. FoundationOne CDx offers oncologists the flexibility in selection of the right therapy for the patients and also ensures that all FDA approved treatment options are being considered. FoundationOne CDx is the next-generation sequencing based in vitro diagnostic device and helps in detection of substitutions, insertion and deletion alerations and genomic signatures as well.
Mia Levy, Chief Medical Officer at Foundation Medicine, said, “Cancer treatment decision-making is growing more complex as we learn more about the mutations that drive cancers to grow and new treatments become available to target those changes.” “We believe securing a third group companion diagnostic approval for FoundationOne CDx is another critical step toward simplifying the decision-making process for oncologists and their patients by allowing them to uncover all FDA approved treatment options for this indication through one test,” he added.
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