U.S. Markets closed
  • S&P 500

    4,397.94
    -84.79 (-1.89%)
     
  • Dow 30

    34,265.37
    -450.03 (-1.30%)
     
  • Nasdaq

    13,768.92
    -385.08 (-2.72%)
     
  • Russell 2000

    1,987.92
    -36.12 (-1.78%)
     
  • Crude Oil

    84.83
    -0.72 (-0.84%)
     
  • Gold

    1,836.10
    -6.50 (-0.35%)
     
  • Silver

    24.34
    -0.37 (-1.50%)
     
  • EUR/USD

    1.1355
    +0.0037 (+0.3293%)
     
  • 10-Yr Bond

    1.7470
    -0.0860 (-4.69%)
     
  • Vix

    28.85
    +3.26 (+12.74%)
     
  • GBP/USD

    1.3546
    -0.0055 (-0.4010%)
     
  • USD/JPY

    113.6550
    -0.4450 (-0.3900%)
     
  • BTC-USD

    35,798.21
    -3,026.20 (-7.79%)
     
  • CMC Crypto 200

    870.86
    +628.18 (+258.85%)
     
  • FTSE 100

    7,494.13
    -90.88 (-1.20%)
     
  • Nikkei 225

    27,522.26
    -250.64 (-0.90%)
     

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

  • Oops!
    Something went wrong.
    Please try again later.
·1 min read
In this article:
  • Oops!
    Something went wrong.
    Please try again later.
  • TMO
  • 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.

See more from Benzinga

© 2021 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.