🧪 List of FDA-Approved Biomarker Tests for Non-Small Cell Lung Cancer

Updated: Jan 22

⚠️ Non–small cell lung cancer (NSCLC) makes up between 80% and 85% of new cases of lung cancer in North America, and among those, the most frequent types of NSCLS are:
- Adenocarcinoma
- Squamous cell carcinoma, and
- Large cell carcinoma.
⚠️The leading cause of cancer-related death in the USA for both men and women is non–small cell lung cancer (NSCLC), and interestingly, it is one of the most preventable forms of cancer death.
The 16 FDA-cleared and approved companion diagnostics devices were developed and used specifically for the identification of biomarkers for targeted therapy of NSCLC, and those are

The cobas EGFR Mutation Test v1 and cobas EGFR Mutation Test v2 (Roche Molecular Systems, Inc.)

Both the cobas EGFR Mutation Test v1 (Roche Molecular Systems, Inc.) and cobas EGFR Mutation Test v2 (Roche Molecular Systems, Inc.) are used to detect deletion and substitution mutations in the EGFR (HER1) gene. You can check more about the EGFR gene in here.

FoundationOne CDx (Foundation Medicine, Inc.) is used to detect deletion and substitution mutations in the EGFR (HER1), BRAF, and MET genes and to detect rearrangements in the ALK gene and gene fusions in the ROS1 gene. If you want to learn more about the ROS1 gene and related gene fusions, please check this particular blog post about the ROS1 gene here.

Similarly, FoundationOne Liquid CDx (Foundation Medicine, Inc.) test is used for detecting deletion and substitution mutations in the EGFR (HER1) and MET genes and for detecting rearrangements in the ALK gene. You can check more about the MET gene here and about the ALK gene here.

Guardant360 CDx (Guardant Health, Inc.) is used to detect deletion and substitution mutations in the EGFR (HER1) gene and mutation in the KRAS gene. You can check more about the KRAS gene here.

ONCO/Reveal Dx Lung & Colon Cancer Assay (O/RDx-LCCA) (Pillar Biosciences, Inc.) is used for the detection of deletion and substitution mutations in the EGFR (HER1) gene.

Oncomine Dx Target Test (Life Technologies Corporation) is used to detect deletion and substitutions mutations in the EGFR (HER1) and BRAF genes, as well as gene fusions in ROS1 and RET genes. If you want to learn more about the BRAF and the RET gene, check these blog posts: All About The BRAF Gene and Understanding ROS1 Gene Fusions and Mutations: Implications for Cancer Diagnosis and Treatment.

Both PD-L1 IHC 22C3 pharmDx (Dako North America, Inc.) and the PD-L1 IHC 28-8 pharmDx (Dako North America, Inc.) are used to detect PD-L1 expression levels.

therascreen EGFR RGQ PCR Kit (Qiagen Manchester, Ltd.) is used to detect deletion and substitutions mutations in the EGFR (HER1) gene.

therascreen KRAS RGQ PCR Kit (Qiagen Manchester, Ltd.) is used to detect deletion and substitution mutations in the KRAS gene. You can check more abou the KRAS gene in this blog post.

Ventana ALK (D5F3) CDx Assay (Ventana Medical Systems, Inc.) detects ALK expression levels.

Both Ventana PD-L1 (SP142) Assay (Ventana Medical Systems, Inc.) and Ventana PD-LI (SP263) Assay (Ventana Medical Systems, Inc) are used for the detection of the PD-L1 expression levels.

Vysis ALK Break Apart FISH Probe Kit (Abbott Molecular Inc.) is used to detect the ALK gene rearrangements.