TMO Receives FDA Approval for Oncomine Dx Target Test

Company Overview - Thermo Fisher Scientific (TMO) received FDA approval for its Oncomine Dx Target Test as a companion diagnostic for identifying patients eligible for HERNEXEOS (zongertinib tablets), a tyrosine kinase inhibitor [1][2] - The Oncomine Dx Target Test enables multi-biomarker analysis from a single tissue sample, providing results in as little as four days, and is fully reimbursed by Medicare and top commercial payers in the U.S. [3] Product Details - The Oncomine Dx Target Test checks for HER2/ERBB2 tyrosine kinase domain activating mutations in NSCLC tumors, reducing the need for second biopsies and avoiding suboptimal therapy selection [3] - The test has received global approvals, including its first FDA approval in 2017, and is reimbursed by insurers covering over 550 million lives globally [4] Market Insights - Lung cancer is the second most common cancer in the U.S., with NSCLC accounting for 85-90% of cases, and approximately 2-4% of NSCLC patients carry a HER2 mutation [5] - The global market for NSCLC treatments is projected to reach $66.04 billion by 2032, growing at a CAGR of 10.3% from 2024 to 2032 [5] Competitive Landscape - Thermo Fisher faces competition from MedTech players like Illumina, which is expanding its NGS oncology portfolio, and Guardant Health, which is enhancing its liquid biopsy and NGS-based testing offerings [7][9] - Illumina's TruSight Oncology assay continues to gain utilization, while Guardant Health's Guardant360 test provides comprehensive tumor profiling from a single blood draw [7][9] Recent Developments - Thermo Fisher also announced FDA approval for the Oncomine Dx Express Test as an in vitro diagnostic assay for use as a companion diagnostic for Dizal's ZEGFROVY (sunvozertinib) [6]