Thermo Fisher Scientific’s Oncomine Dx Target Test Receives US FDA Approval as a Companion Diagnostic
Shots:
- The US FDA has approved Ion Torrent Oncomine Dx Target Test as a companion diagnostic to identify pts with NSCLC harboring HER2/ERBB2 TKD activating mutations
- Oncomine Dx Target allows clinicians to identify pts eligible for treatment with Bayer’s HER2-directed therapy Hyrnuo (sevabertinib) for locally advanced or metastatic non-squamous NSCLC
- Oncomine Dx Target Test, first FDA-approved in 2017 as an NGS companion diagnostic, has gained approvals in 20 countries for 11 biomarkers & 20+ targeted therapies, & in the US is authorized for use with multiple therapies across NSCLC & other tumor types
Ref: Bussinesswire| Image: ThermoFisher| Press Release
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