FDA Approves Oncomine Dx Target Test to Identify EGFR Exon 20 Insertion Mutations in NSCLC Eligible for Amivantamab

Oncomine Dx Target Test has been approved by the FDA as a companion diagnostic to identify EGFR exon 20 insertion mutations in patients with non–small cell lung cancer who may undergo treatment with amivantamab.

A companion diagnostic, Oncomine Dx Target Test, was approved by the FDA to identify EGFR exon 20 insertion mutations in patients with non–small cell lung cancer (NSCLC) who may be eligible for treatment with amivantamab-vmjw (Rybrevant), according to a press release from the developer, Thermo Fisher Scientific.1

The approval marks the second indication for the Oncomine Dx Target Test for patients with EGFR exon 20 insertion mutations, as well as being the twelvth global indication for those with NSCLC. The test can assess 23 genes at a time that are associated with NSCLC. Currently, it is the only FDA-approved next-generation sequencing (NGS) CDx that can be used on formalin-fix, paraffin-embedded (FFPE) tissue in order to determine whether patients are eligible for treatment with amivantamab for those who have progressed on or following treatment with platinum-based chemotherapy.

“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,” Garret Hampton, president of clinical next-generation sequencing and oncology at Thermo Fisher Scientific, said in the press release. “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 [amivantamab] globally to help improve outcomes for more patients.”

Amivantamab was granted accelerated approval by the FDA in May 2021 for patients with metastatic EGFR exon 20 insertion–mutant NSCLC following progression on or after chemotherapy.2 The bispecific antibody targets EGFR exon 20 insertion mutations that are detected via an FDA-approved test. Additionally, the regulatory organization also approved Guardant360 CDx as a companion diagnostic for amivantamab.

The approval was based on findings from the multicenter, non-randomized, open label, multi-cohort phase 1 CHRYSALIS study (NCT02609776), which includes patients with locally advanced or metastatic, EGFR exon 20 insertion–mutant NSCLC who had progressive disease on or following platinum-based chemotherapy. Investigators reported the agent yielded an overall response rate of 40% (95% CI, 29%-51%) and a median duration of response of 11.1 months (95% CI, 6.9–not evaluable).

The most common adverse effects included rash, infusion-related reactions, paronychia, musculoskeletal pain, dyspnea, nausea, fatigue, edema, stomatitis, cough, constipation, and vomiting.


  1. FDA approves NGS-based companion diagnostic for EGFR exon20 insertion mutant non-small cell lung cancer tumor tissue. News release. Thermo Fisher Scientific. December 9, 2021. Accessed December 9, 2021. https://bit.ly/3pJWxHE
  2. FDA grants accelerated approval to amivantamab-vmjw for metastatic non-small cell lung cancer. News release. FDA. May 21, 2021. Accessed December 9, 2021. https://bit.ly/3lMd5hi