Thermo Fisher Scientific announced that its Ion Torrent™ Oncomine™ Dx Target Test received U.S. Food and Drug Administration clearance on November 19 2025 as a companion diagnostic for Bayer’s newly approved HER2‑directed therapy HYRNUO™ (sevabertinib). The test detects HER2 mutations in non‑small‑cell lung‑cancer (NSCLC) tumor samples, enabling clinicians to identify patients who can benefit from the targeted therapy that was approved a day later on November 20 2025.
The approval addresses a critical gap in the HER2‑mutant NSCLC market, which represents roughly 2 % of all NSCLC cases. Historically, many eligible patients miss out on therapy because of testing delays and bottlenecks. By providing a rapid, high‑throughput next‑generation sequencing platform, Thermo Fisher’s test shortens the diagnostic turnaround and improves access to HYRNUO, strengthening the therapeutic value chain for Bayer and its patients.
Thermo Fisher’s Q3 2025 financial results underscore the commercial momentum behind the new diagnostic. Total revenue rose to $11.12 billion, up 5 % year‑over‑year, while adjusted earnings per share reached $5.79, beating consensus estimates by $0.29. The company’s adjusted operating margin expanded to 23.3 % from 22.3 % in Q3 2024, driven by pricing power in core segments and disciplined cost management. The earnings beat reflects a combination of higher test volumes, favorable mix shifts toward high‑margin oncology diagnostics, and effective operational leverage.
CEO Marc N. Casper highlighted the achievement, saying, “Our team did an outstanding job and delivered excellent operational performance in the quarter, reflecting the strength of our proven growth strategy, the power of our PPI Business System, and the continued active management of our company.” The partnership with Bayer not only adds a new revenue stream from test usage fees but also positions Thermo Fisher as a key co‑marketing partner, deepening its foothold in the precision‑medicine market and creating a pipeline for future companion‑diagnostic approvals.
The competitive landscape remains active, with Boehringer Ingelheim’s Hernexeos also receiving FDA clearance for a similar indication. Nevertheless, Thermo Fisher’s early entry and broad regulatory footprint—20‑country approval for 11 biomarkers and over 20 targeted therapies—give it a strategic advantage. The Oncomine Dx Target Test’s approval is expected to accelerate the company’s growth trajectory, reinforce its diagnostic portfolio, and enhance its partnership with Bayer in the expanding NSCLC market.
In summary, the FDA clearance of the Oncomine Dx Target Test marks a significant milestone for Thermo Fisher, reinforcing its leadership in oncology diagnostics, boosting its financial performance, and expanding its collaboration with Bayer to deliver timely, targeted therapy to patients with HER2‑mutant NSCLC.
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