FDA Clears Thermo Fisher's Companion Diagnostic Test For Bile Duct Cancer Drug

The FDA has granted pre-market approval to Thermo Fisher Scientific Inc's TMO Oncomine Dx Target Test.
The approval for the test comes as a companion diagnostic to identify patients with isocitrate dehydrogenase-1 (IDH1) mutated cholangiocarcinoma (CCA) who may be candidates for treatment with ivosidenib (Servier Pharmaceuticals' Tibsovo).
The Oncomine Dx Target Test is a sequencing assay that looks for mutations in the IDH1 gene clinically associated with CCA.
The FDA first approved the test as a CDx in 2017, and it is now approved for four targeted therapies for non-small cell lung cancer and one targeted therapy for CCA in the US.
The test is also currently approved in more than 15 countries, including the US, various countries in Europe, Japan, South Korea, and the Middle East.
Thermo Fisher further noted that it had signed an agreement with Servier to develop and commercialize a CDx using its research-use-only Oncomine Precision Assay to identify low-grade glioma patients with IDH1 and IDH2 mutations.
Related content: Benzinga's Full FDA Calendar
Price Action: TMO shares are up 0.40% at $550.29 during the market session on the last check Thursday.