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FDA Clears Thermo Fisher Scientific Oncomine Assay as CDx for Bile Duct Cancer Drug

NEW YORK – Thermo Fisher Scientific said on Wednesday that the US Food and Drug Administration has granted pre-market approval to the company's Oncomine Dx Target Test 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).

Ivosidenib is an IDH1 inhibitor that is approved for the treatment of adult patients with previously treated, locally advanced or metastatic CCA with an IDH1 mutation as detected by an FDA-approved test. The therapy is also approved in the US as monotherapy for the treatment of adults with IDH1-mutated relapsed or refractory acute myeloid leukemia and for adults with newly diagnosed IDH1-mutated AML who are 75 or older and who have comorbidities that preclude the use of intensive induction chemotherapy, Thermo Fisher said.

The Oncomine Dx Target Test is a next-generation 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 company said. 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 has 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 who may be eligible for the pharmaceutical company's treatment vorasidenib.

"Advances in genetic profiling through NGS have enabled identification of an increasing number of cancer-driving genomic variations, opening the door for the development of more targeted treatment options," Garret Hampton, president of clinical next-generation sequencing and oncology at Thermo Fisher Scientific, said in a statement. "By continuing to work with our pharmaceutical partners to co-develop diagnostics for these life-changing therapies and expanding the clinical utility of our tests, we hope to help more cancer patients around the world receive more targeted and effective treatment."