Thermo Fisher’s Oncomine Dx Target Test Receives the US FDA’s Approval as a CDx for the Treatment of IDH1-Mutated Cholangiocarcinoma

August 26, 2021 Auto Bot approval, FDA, MedTech, regulatory, Thermo Fisher 0

Shots:

  • The FDA has approved the Oncomine Dx target test as a CDx to identify patients with IDH1 mutated CCA who may be candidates for Servier’s Tibsovo
  • Oncomine Dx Target Test is NGS based CDx test that provides robust results in the IDH1 gene clinically associated with CCA & is currently approved in 15+ countries, including the US, EU, Japan, South Korea & Middle East. The test had received the 1st FDA’s approval in 2017 & is now approved for 4 targeted therapies for NSCLC & 1 for CCA in the US
  • Thermo Fisher & Servier collaborated to develop & commercialize a CDx supporting Oncomine precision assay to identify LGG patients with IDH1 & 2 mutations who may be eligible for vorasidenib

Click here to­ read full press release/ article | Ref: PR Newswire | Image: CPhl Online

The post Thermo Fisher’s Oncomine Dx Target Test Receives the US FDA’s Approval as a CDx for the Treatment of IDH1-Mutated Cholangiocarcinoma first appeared on PharmaShots.