FDA Approves FoundationOne CDx in NSCLC

The FoundationOne CDx diagnostic was approved as a companion diagnostic to help identify EGFR 19 deletions or exon 21 alterations in non–small cell lung cancer.

The FDA has approved FoundationOne CDx as a companion diagnostic for patients with non–small cell lung cancer (NSCLC) who have EGFR exon 19 deletions or exon 21 alteration who are eligible for EGFR tyrosine kinase inhibitors, according to a press release from Foundation Medicine.1

The designation was part of an innovative, efficient regulatory approach intended to make the companion diagnostic approval process simpler for partners of Foundation Medicine that are creating EGFR inhibitors and targeted therapies without sacrificing quality.

Clinicians can also utilize this diagnostic for tumor mutation profiling for those with solid neoplasms.

“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. 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, MD, PhD, chief medical officer at Foundation Medicine, said in the press release.

FoundationOne CDx is a next-generation sequencing based in vitro diagnostic tool that detects substitutions, insertions, deletion alteration, and copy number alterations in 324 genes. This diagnostic can also distinguish gene rearrangements and genomic signatures including microsatellite instability (MSI) and tumor mutational burden.

The device uses formalin-fixed, paraffin-embedded tumor tissue specimens to identify these genomic signatures. Additionally, FoundationOne CDx is a prescription only diagnostic, and it’s intended use is for patients who may benefit from treatment with specific therapies.

The press release cautions that the test does not mean patients will be matched to a treatment, and a negative test result does not mean there isn’t an alteration. Clinicians may need to order a biopsy to confirm.

The diagnostic now allows clinicians to have flexibility when deciding which regimen to treat their patients with.

FoundationOne CDx is also approved in number other indications that include osimertinib (Tagrisso) for NSCLC with EGFR exon 19 deletions or EGFR 21 L858R alterations, trastuzumab (Herceptin) for HER2-positive breast cancer, cetuximab (Erbitux) for KRAS wild-type colorectal cancer, olaparib (Lynparza) or rucaparib (Rubraca) for ovarian cancer with BRCA1/2 alterations, and pembrolizumab (Keytruda) for MSI-high solid tumors.2


1. US FDA approves FoundationOnce CDx as a companion diagnostic for EGFR therapeutics targeting exon 19 deletions of exon 21 substitutions in non–small cell lung cancer. News Release. March 17, 2022. Accessed March 17, 2022. https://bit.ly/3wfLUS6

2. List of cleared or approved companion diagnostic devices (in vitro and imaging tools). News release. FDA. December 1, 2021. Accessed March 17, 2022. https://bit.ly/3h0FD3R