Thermo Fisher Scientific’s companion diagnostic test that is used to identify targeted therapies for certain non-small cell lung cancer patients was granted premarket approval by the U.S. Food and Drug Administration (FDA).

Thermo Fisher Scientific’s Oncomine Dx Target Test is a companion diagnostic (CDx) that aims to aid non-small cell lung cancer (NSCLC) patients whose tumors carry epidermal growth factor receptor (EGFR) Exon20-insertion mutations for potential treatment with RYBREVANT (amivantamab-vmjw), Janssen Biotech, Inc.’s (Janssen’s) targeted therapy.

“The FDA’s approval of Oncomine Dx Target Test enables clinicians to use FFPE tissue samples to identify patients in the U.S. who may benefit from this important new therapy,” says Garret Hampton, president, clinical next-generation sequencing and oncology at Thermo Fisher Scientific. “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. We look forward to expanding registration of the test as a companion diagnostic for RYBREVANT globally to help improve outcomes for more patients.”

The Oncomine Dx Target Test simultaneously evaluates 23 genes associated with NSCLC.

This is the second approval for Oncomine Dx Target Test as a CDx for EGFR Exon20 insertion mutant patients. The test is an FDA-approved next-generation sequencing (NGS) CDx on formalin-fixed, paraffin-embedded (FFPE) tissue for determining RYBREVANT eligibility in patients whose disease has progressed on or after platinum-based chemotherapy. 

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.

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. The test has also been approved by Japan’s Ministry of Health, Labour and Welfare (MHLW) as a CDx for five biomarkers – EGFR, ALK, ROS1, BRAF, and RET – associated with 10 targeted therapies for NSCLC.

To learn more visit Thermo Fisher Scientific online.

Featured image: Microscopic image of a cytology of a non-small cell lung tumor.