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U.S. FDA Approves FoundationOne®CDx as a Companion Diagnostic for EGFR Therapeutics Targeting Exon 19 Deletions or Exon 21 Substitutions in Non-Small Cell Lung Cancer

Foundation Medicine’s tissue-based test is the first and only comprehensive genomic profiling test to be approved as a companion diagnostic for a third group of targeted therapies

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Foundation Medicine, Inc. a pioneer in molecular profiling for cancer, today announced it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne®CDx to be used as a companion diagnostic to identify patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) EGFR exon 19 deletions or exon 21 (L858R) alterations and are appropriate for treatment with EGFR Tyrosine Kinase Inhibitors (TKI) approved by FDA for this indication.

EGFR mutations are the second most common oncogenic drivers in NSCLC. Deletions in exon 19 and substitutions in exon 21 account for roughly 85 percent of observed EGFR mutations in NSCLC.1 As a companion diagnostic for therapies targeting these mutations in NSCLC, FoundationOne®CDx offers oncologists flexibility when selecting the right therapy for their patients and ensures all FDA approved treatment options are considered within this group of therapies.

“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,” said Mia Levy, M.D., Ph.D., chief medical officer at Foundation Medicine. “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.”

In addition to driving efficiency in clinical care, this approval is part of an innovative, efficient regulatory approach that simplifies the companion diagnostic approval process for Foundation Medicine’s biopharma partners developing EGFR inhibitor therapeutics targeting EGFR exon 19 deletions or exon 21 alterations in NSCLC while maintaining rigorous quality standards.

About FoundationOne CDx

FoundationOne CDx is a next-generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens. FoundationOne CDx is for prescription use only and is intended as a companion diagnostic to identify patients who may benefit from treatment with certain targeted therapies in accordance with their approved therapeutic product labeling. Additionally, FoundationOne CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Some patients may require a biopsy. For a full list of targeted therapies for which FoundationOne CDx is indicated as a companion diagnostic, please visit

About Foundation Medicine

Foundation Medicine is a molecular information company dedicated to a transformation in cancer care in which treatment is informed by a deep understanding of the genomic changes that contribute to each patient's unique cancer. The company offers a full suite of comprehensive genomic profiling assays to identify the molecular alterations in a patient’s cancer and match them with relevant targeted therapies, immunotherapies and clinical trials. Foundation Medicine’s molecular information platform aims to improve day-to-day care for patients by serving the needs of clinicians, academic researchers and drug developers to help advance the science of molecular medicine in cancer. For more information, please visit or follow Foundation Medicine on Twitter (@FoundationATCG).

Foundation Medicine® and FoundationOne® are registered trademarks of Foundation Medicine, Inc.

Source: Foundation Medicine

1 Peter T. Harrison, Simon Vyse, Paul H. Huang. “Rare epidermal growth factor receptor (EGFR) mutations in non-small cell lung cancer.”

Foundation Medicine:
Erin Smith, 262-914-2779


Source: Foundation Medicine

March 18, 2022