FDA Approves NGS-Based Companion Diagnostic for EGFR Exon20 Insertion Mutant Non-Small Cell Lung Cancer Tumor Tissue

CARLSBAD, Calif.: CARLSBAD, Calif., Dec. 9, 2021 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) has granted premarket approval to Thermo Fisher Scientific’s Oncomine Dx Target Test as a companion diagnostic (CDx) to help identify 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," said 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…
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