You can depend on a team of proven, IVD-experienced project managers, highly qualified scientists, manufacturing, quality and regulatory experts. Our commercial team works with us in tandem, enabling us to move seamlessly through each phase - from R&D through clinical and commercialization. All teams have a deep understanding of the oncology testing landscape.
Together, we ensure that product design requirements reflect customer and market needs from an analytic performance, end-user and economic perspective.
The expertise and global reach to support
One Size DOES NOT Fit All
Extensive tools menu spans all stages of drug development
Over 600 labs in across the world rely on our technology
Worldwide CDx Expertise
CDx approvals in multiple countries
In oncology clinical research, a single solution can never fit all the different interactions, samples, and tumors to be tested.
That's why we equip you with a whole spectrum of solutions for tumor profiling from FFPE tissue samples to liquid biopsy.
Our streamlined end-to-end workflows, relevant test menus, and support are empowering laboratories around the world to adopt NGS and move precision oncology forward.
Oncomine Dx Target Test was the first, and is still the only commercially distributable multiple biomarker CDx test based on NGS, which can be implemented in new laboratories around the world.
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Oncomine Dx Target Test (Next-Generation Sequencing) was approved by the FDA in 2017, followed by self-declaration and launch of a CE marked version in Europe and approval in South Korea in 2018, and by MHLW in Japan in 2019.