The Food and Drug Administration (FDA) on Wednesday granted accelerated approval to Bayer AG‘s (OTC:BAYRY) Hyrnuo (sevabertinib) for adults with a specific type of advanced lung cancer.The approval covers locally advanced or metastatic, non-squamous non-small cell lung cancer whose tumors have HER2 tyrosine kinase domain activating mutations and who have received a prior systemic therapy.The FDA also approved the Oncomine Dx Target Test (Life Technologies Corporation) as a companion diagnostic device to aid ...

Core Insights - Thermo Fisher Scientific Inc. (TMO) is set to announce its third-quarter 2025 results on October 22, with expectations of modest year-over-year growth in revenues and earnings [1][9]. Revenue and Earnings Estimates - The Zacks Consensus Estimate for TMO's revenues is $10.89 billion, reflecting a 2.8% increase from the same quarter last year [2]. - The consensus estimate for earnings is $5.50 per share, indicating a 4.2% growth compared to the previous year's quarter [2]. Estimate Revision Trend - Over the past 30 days, estimates for TMO's third-quarter earnings have decreased by 0.2% to $5.50 per share [3]. Segment Performance Expectations - The Analytical Instruments segment is anticipated to report strong sales, with expected revenues of $1.87 billion, representing a 3.4% year-over-year growth [6]. - The Life-Science Solutions segment is projected to generate $2.41 billion in revenues, indicating a 1.2% improvement year over year [11]. - The Specialty Diagnostics segment is expected to achieve revenues of $1.18 billion, suggesting a 4.2% growth year over year [13]. - The Laboratory Products and Services segment is forecasted to report revenues of $5.89 billion, reflecting a 2.7% year-over-year growth [15]. Key Developments and Innovations - TMO launched new products in the Analytical Instruments segment, including the Scios 3 and Talos 12 electron microscopes, and the Hypulse Surface Analysis System [4][5]. - The company completed the acquisition of Solventum's Purification & Filtration business for approximately $4.0 billion, enhancing its bioproduction capabilities [7]. - New product launches in the Life-Science Solutions segment include Gibco Efficient-Pro Medium (+) Insulin and the Olink Target 48 Neurodegeneration panel [8]. - TMO received FDA approvals for several diagnostic tests, which are expected to positively impact its third-quarter performance [12]. Strategic Initiatives - TMO opened the Advanced Therapies Collaboration Center (ATxCC) in Carlsbad, CA, to support the development of cell therapies [10]. - The company expanded its manufacturing capabilities by acquiring Sanofi's sterile fill-finish and packaging site in Ridgefield, NJ [14].

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]