Thermo Fisher Scientific said the U.S. Food and Drug Administration (FDA) has granted premarket approval to the company’s Oncomine Dx Target Test as a companion diagnostic to help identify non-small cell lung cancer (NSCLC) patients whose tumors carry epidermal growth factor receptor (EGFR) Exon20-insertion mutations.
The test will help clinicians determine if these patients would benefit from treatment with RYBREVANT (amivantamab-vmjw), which is a targeted therapy from Janssen Biotech.
Garret Hampton, President, Clinical Next-Generation Sequencing and Oncology at Thermo Fisher Scientific, said, "in situations where conventional testing may miss key mutations that could match patients with targeted therapies, NGS technology is vital to make these connections and advance precision medicine.”
This is the second approval for Oncomine Dx Target Test as a CDx for EGFR Exon20 insertion mutant patients and the 12th NSCLC global approval overall.
Lung cancer is the leading cause of cancer deaths worldwide. EGFR mutations are an important therapeutic target in NSCLC; EGFR Exon20 insertion mutations, specifically, are associated with resistance to immune checkpoint inhibitor therapies and poor patient prognosis. Further, EGFR Exon20 insertion mutations are often under-detected by conventional, single-gene testing methods. This is driving the need for more comprehensive biomarker testing with NGS technology, which simultaneously interrogates multiple biomarkers for early identification and appropriate characterization of cancer patient samples.
Thermo Fisher's Oncomine Dx Target Test simultaneously evaluates 23 genes associated with NSCLC. The FDA first approved the test as a CDx in 2017, and it is now approved in the U.S. for six targeted therapies for NSCLC and one for cholangiocarcinoma.
