In a landmark collaboration, Thermo Fisher initiated development of the first multi-marker NGS-based CDx designed to match NSCLC patients with clinical trials and targeted therapies, setting the stage for a universal testing model in precision oncology.
The Oncomine Dx Target Test became the first FDA-approved distributable NGS-based companion diagnostic–marking a pivotal moment in expanding access to genomic testing and enabling broader clinical adoption.
The Oncomine Dx Target Test achieved regulatory approvals across Japan, South Korea, and Europe, establishing an international footprint and enabling patients in multiple regions to benefit from precision oncology and targeted therapies.
The Oncomine Dx Express Test received CE-IVD marking, offering end-to-end automation and rapid results in as little as 24 hours–bringing decentralized NGS testing closer to routine care across Europe.
The Oncomine Dx Target Test achieved EU IVDR certification, adapting to Europe’s evolving regulatory landscape and readiness for the next generation of regulatory expectations.