On March 17, 2022 Foundation Medicine, Inc. a pioneer in molecular profiling for cancer, reported it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOneCDx 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 (Press release, Foundation Medicine, MAR 17, 2022, View Source [SID1234610281]).

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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, FoundationOneCDx 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 View Source