Oncomine Dx Target Test is a next-generation sequencing (NGS)-based CDx that simultaneously evaluates 23 genes related to NSCLC
US FDA approves Thermo Fisher’s Oncomine Dx as CDx. (Credit: Thermo Fisher Scientific Inc.)
The US Food and Drug Administration (FDA) has approved Thermo Fisher Scientific’s Oncomine Dx target test as a companion diagnostic (CDx) to identify patients eligible for Rybrevant.
It was indicated for use in non-small cell lung cancer (NSCLC) patients, with epidermal growth factor receptor (EGFR) Exon20-insertion mutation.
Oncomine Dx Target Test is a next-generation sequencing (NGS)-based CDx, designed to simultaneously evaluate 23 genes related to NSCLC.
The test was initially approved as a CDx by the FDA in 2017, and is currently approved in the US for six targeted therapies for NSCLC and one for cholangiocarcinoma.
It was also approved by Japan’s MHLW, as a CDx for five biomarkers, EGFR, ALK, ROS1, BRAF, and RET, associated with 10 targeted therapies for NSCLC.
The current FDA premarket approval marks the second regulatory approval for the target test, as a CDx for EGFR Exon20 insertion mutant patients.
Thermo Fisher Scientific clinical next-generation sequencing and oncology president Garret Hampton said: “The FDA’s approval of Oncomine Dx Target Test enables clinicians to use FFPE tissue samples to identify patients in the US who may benefit from this important new therapy.
“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.”
EGFR Exon20 insertion mutations are associated with resistance to immune checkpoint inhibitor therapies and are often under-detected by conventional testing methods.
According to Thermo Fisher, Oncomine Dx is the only globally distributable NGS CDx solution approved in more than 15 countries.
Rybrevant (amivantamab-vmjw) is an FDA-approved prescription medicine indicated for the treatment of NSCLC patients with EGFR exon 20 insertion mutations.
The drug was developed by Janssen, a pharmaceutical company of Johnson and Johnson (J&J), and was granted FDA approval in May this year.
The US regulator also approved Guardant Health’s Guardant360 CDx as a companion diagnostic to identify patients eligible for Rybrevant.