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David S. Ettinger, MD, FACP, FCCP


FDA Brief: Companion Diagnostic Approved for NSCLC With EGFR Mutations

By: Lauren Velentzas
Posted: Wednesday, March 23, 2022

The U.S. Food and Drug Administration (FDA) recently approved the sequencing-based in vitro FoundationOne CDx as a companion diagnostic for identifying epidermal growth factor receptor (EGFR) mutations (exon 19 deletions or exon 21 alterations) in non–small cell lung cancer (NSCLC). The companion diagnostic has previously been approved for the detection of genetic variations in patients who may benefit from therapies for HER2-positive breast cancer, melanoma, colorectal cancer, ovarian cancer, prostate cancer, and tumor mutational burden for solid tumors. It uses formalin-fixed, paraffin-embedded tumor tissue specimens to identify genomic signatures and to distinguish gene rearrangements and genomic signatures.

FoundationOne CDx is for prescription use only by qualified health-care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms. Its use is intended solely for patients who may benefit from select therapies, and not all patients who are tested may match to treatment.

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