FDA Approves FoundationOne® Liquid CDx as a Companion Diagnostic for TKIs in EGFR-Mutant NSCLC

The FDA has approved the FoundationOne^® Liquid CDx as a companion diagnostic to identify patients with non–small cell lung cancer (NSCLC) whose tumors have EGFR exon 19 deletions or exon 21 L858R substitutions and are appropriate for treatment with current and future EGFR TKIs approved by the FDA for this indication.¹

With this approval, FoundationOne Liquid CDx can be used as a companion diagnostic for erlotinib (Tarceva), osimertinib (Tagrisso), and gefitinib (Iressa). Moving forward, FoundationOne Liquid CDx will become a companion diagnostic for future TKIs within this population that are approved by the FDA.

“For [patients with] NSCLC whose tumors have EGFR exon 19 deletions or exon 21 substitutions, this approval opens new access avenues for targeted treatment options,” Mia Levy, MD, PhD, chief medical officer at Foundation Medicine, said in a press release.

“Following three recent group companion diagnostic approvals for Foundation Medicine’s tissue-based test, FoundationOne® CDx, this first group approval for FoundationOne Liquid CDx builds upon the momentum for more efficient and innovative regulatory approaches to the companion diagnostic approval process. These efforts help to maintain the high-quality standards and rigor of the process, while streamlining the approach to developing TKIs to get these treatments to patients faster.”

FoundationOne Liquid CDx is a qualitative next-generation sequencing–based in vitro diagnostic test that uses targeted high throughput hybridization-based capture technology to evaluate 324 genes utilizing cell-free DNA (cfDNA) isolated from plasma derived from anti-coagulated peripheral blood.

The test is approved to identify short variants in more than 300 genes and is a companion diagnostic to identify patients who may benefit from treatment with specific therapies.

In August 2020, the FDA approved the FoundationOne Liquid CDx for all solid tumors with several companion diagnostic indications.²

The approval was based on analytical and clinical validation studies that collected over 7500 samples and 30,000 unique variants across more than 30 tumor types. When investigators analyzed the platform across these varied tumors, the test showed high sensitivity and specificity, even at the low allele frequencies that were noted in the collected blood samples.

The assay is intended to be utilized as a tool to help inform treatment decisions in accordance with FDA-approved labeling and professional guidance for patients with solid tumors.

References

1. Foundation Medicine Receives FDA Approval for FoundationOne®Liquid CDx as a Companion Diagnostic for a Certain Group of Tyrosine Kinase Inhibitors for Treatment of Non-Small Cell Lung Cancer Patients. News release. Foundation Medicine, Inc. December 21, 2022. Accessed December 21, 2022. https://bit.ly/3YxRHxQ
2. FDA approves Foundation Medicine’s FoundationOne Liquid CDx, a comprehensive pan-tumor liquid biopsy test with multiple companion diagnostic indications for patients with advanced cancer. News release. Foundation Medicine. August 26, 2020. Accessed December 21, 2022. https://bit.ly/2EtxNQs