Benzinga | Aug 26, 2021 12:17PM EDT

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 (NYSE: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.