Companion Diagnostics
News on companion diagnostics and drug/test co-development.
FDA Approves Takeda's Exkivity With Thermo Fisher CDx for EGFR Exon20 Insertion-Positive NSCLC
This is the first time the FDA has approved a drug specifically for NSCLC patients who harbor rare EGFR Exon20 insertion mutations.
Japanese Health Ministry Clears Thermo Fisher Scientific Oncomine Assay as CDx for Lung Cancer Drug
The Oncomine Dx Target Test can now be used to identify patients with RET-fusion positive NSCLC who may be treated with Eli Lilly's selpercatinib.
Illumina, Merck Partner to Advance Homologous Recombination Deficiency CDx, Research Assay
Under the terms of the deal, Illumina will develop a new HRD CDx for the EU and UK markets and a research-use only HRD assay that will be add-on content for its TSO 500 panel.
Thermo Fisher Scientific, AstraZeneca Team up to Develop CDx for Targeted Drugs
The next-generation sequencing based companion diagnostics will be paired with targeted therapies that are being developed for several diseases.
FDA Clears Thermo Fisher Scientific Oncomine Assay as CDx for Bile Duct Cancer Drug
The Oncomine Dx Target Test can now be used to identify patients with IDH1-mutated cholangiocarcinoma who may be candidates for ivosidenib.