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FDA Approves FoundationOne CDx for EGFR Inhibitors to Identify EGFR Mutations in NSCLC

NEW YORK – Foundation Medicine said on Thursday that the US Food and Drug Administration has approved its FoundationOne CDx test as a companion diagnostic to identify non-small cell lung cancer patients with EGFR exon 19 deletions or exon 21 alterations for treatment with EGFR inhibitors.

The next-generation sequencing test will help select patients for treatment with EGFR inhibitors approved by the FDA, such as AstraZeneca's Tagrisso (osimertinib), Genentech's Tarceva (erlotinib), Boehringer Ingelheim's Gilotrif (afatinib), and AstraZeneca's Iressa (gefitinib).

"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," Mia Levy, chief medical officer at Foundation Medicine, said in a statement.

Last last year, FoundationOne CDx was also approved as a companion diagnostic for two groups of BRAF inhibitor therapies for melanoma patients.