FoundationOne CDx receives FDA approval for non-small cell lung cancer patients

March 2022 Pharma News Nalinee Pandey
Lung cancer cells, SEM

The FDA approves FoundationOne CDx as a companion diagnostic to identify EGFR alterations in non-small cell lung cancer (NSCLC).

According to a press release from Foundation Medicine, FDA has approved FoundationOne CDx as a companion diagnostic for NSCLC patients who have EGFR exon 19 deletions or exon 21 alteration and are eligible for EGFR tyrosine kinase inhibitors.

FoundationOne CDx is a next-generation sequencing-based tool that can detect substitutions, insertions, deletions and copy number changes in 324 genes. This diagnostic tool can detect gene rearrangements and genomic signatures such as microsatellite instability (MSI) and tumour mutational burden. The device used DNA isolated from formalin-fixed, paraffin-embedded tumour tissue specimens. It is essential to underline that FoundationOne CDX is only a diagnostic tool, and it’s intended for patients who may benefit from specific therapies. The researchers caution that the test does not mean that patients will be matched to treatment, and a negative test does not guarantee an absence of alteration.

“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 also approved in other malignancies such as HER2-positive breast cancer, colorectal cancer, ovarian cancer and MSI-high solid tumours.


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.