Thermo Fisher Expands Diagnostic Portfolio with FDA Clearances and Automation Innovations
Event summary
- Thermo Fisher received FDA 510(k) clearance for its EXENT® Solution, an automated mass spectrometry platform for diagnosing multiple myeloma.
- The Oncomine™ Dx Express Test on the Ion Torrent™ Genexus™ Dx Integrated Sequencer gained FDA approval in 2025 as a companion diagnostic for non–small cell lung cancer.
- Thermo Fisher launched the EliA™ CTD 13 Screen, an autoimmune disease diagnostic tool cleared by the FDA in June 2026.
The big picture
Thermo Fisher's latest innovations align with the growing demand for faster, more accurate diagnostics in oncology and autoimmune diseases. The company's focus on automation and regulatory milestones underscores its strategic shift towards precision medicine, positioning it as a key player in the evolving healthcare landscape.
What we're watching
- Regulatory Momentum
- Whether Thermo Fisher can sustain its pace of FDA clearances for diagnostic tools, enhancing its market position.
- Automation Impact
- How the integration of automated workflows will affect laboratory efficiency and diagnostic accuracy.
- Market Expansion
- The pace at which Thermo Fisher can expand its diagnostic portfolio into new clinical areas, addressing unmet needs.
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