Thermo Fisher's Oncomine Dx Target Test Receives Additional CDx Approval in Japan for RET-Positive Thyroid Cancers
Thermo Fisher Scientific
Biotechnology Product Developer
Eli Lilly
Global Pharmaceutical R&D and Production Company
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NEWS
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Recently, Japan's regulatory agency, the Ministry of Health, Labour and Welfare (MHLW), has once again approvedThermo Fisher Ion Torrent™ Oncomine™ Dx Target Test (hereinafter referred to as ODxTT) as a companion diagnostic (CDx) for next-generation sequencing (NGS), detectsRETFusion-Positive Thyroid Cancer andRETPatients with mutation-positive medullary thyroid carcinoma are treated with Eli Lilly's tyrosine kinase inhibitor Selpercatinib.
This is the 14th CDx approval for the ODxTT kit, andFirst Approval for Use in Thyroid Cancer Companion Diagnostics, gradually achieving another milestone for Thermo Fisher Scientific in advancing precision oncology, and continuing to strive towards the goal of ensuring global patients receive appropriate targeted therapies.
Currently, ODxTT has been approved in Japan for ten targeted therapies associated with five biomarkers for non-small cell lung cancer (NSCLC) and thyroid cancer patients.
CDx Marker | Targeted drug/therapy |
BRAF V600EMutation | Dabrafenib Combined with Trametinib |
EGFRMutation | Afatinib, Gefitinib, Erlotinib, Osimertinib |
ALK Integration | Alectinib, Crizotinib |
ROS1Integration | Crizotinib, Entrectinib |
RETIntegration | Selpercatinib(Loxo-292) |
OFA is the first FDA-approved companion diagnostic kit ODxTT research edition based on the NGS platform, utilizing Ion Ampliseq™ technology. It is suitable for FFPE tissue samples and enables NGS multi-target detection with a starting nucleic acid quantity as low as 10ng.
Based on the Ion Torrent™ Genexus™ Integrated NGS PlatformOncomine™ Precision Assay(OPA), covering50 Tumor Markers, such asEGFR、ALK、KRAS、BRAF、ROS1、NTRK、RET、HER2、ERBB2, etc.), can be applied to FFPE samples and liquid biopsy samples, and comprehensive NGS results can be obtained in a short period of time.
Further Reading:
● Learn about the latest developments of OPA in the field of companion diagnostics
Another large pan-cancer assay kit –Oncomine™ Comprehensive Assay Plus(OCA Plus) Covers more than 500 tumor-related driver genes, including various types of mutations: SNVs, insertions/deletions, CNVs, fusions, splice variants, HRD, as well as MSI and TMB for immunotherapy markers.
Further Reading:
● Learn about the latest developments in OCA plus in the companion field