ALK IHC companion diagnostic - Ventana Medical Systems

Drug Profile

ALK IHC companion diagnostic - Ventana Medical Systems

Alternative Names: Alectinib companion diagnostic - Ventana Medical Systems; ALK gene rearrangement diagnostic - Ventana MEdical Systems; Crizotinib companion diagnostic - Ventana Medical Systems; RG 7853 companion diagnostic - Ventana Medical Systems; VENTANA ALK (D5F3) CDx Assay; VENTANA ALK IHC diagnostic test

Latest Information Update: 09 Nov 2017

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At a glance

  • Originator Ventana Medical Systems
  • Developer Roche; Ventana Medical Systems
  • Class Diagnostic agents; Monoclonal antibody diagnostics
  • Mechanism of Action
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity No

Highest Development Phases

  • Marketed Non-small cell lung cancer

Most Recent Events

  • 07 Nov 2017 US FDA approves VENTANA ALK (D5F3) CDx Assay as a companion diagnostic for alectinib in Non-small cell lung cancer (Diagnosis, ALK-positive) in USA
  • 14 Sep 2017 Phase-III development of VENTANA ALK (D5F3) CDx Assay as a companion diagnostic for alectinib in Non-small cell lung cancer (Diagnosis, ALK-positive) is ongoing in USA, Australia, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Costa Rica, France, Germany, Guatemala, Greece, Egypt, Hong Kong, Israel, Italy, South Korea, Mexico, New Zealand, Poland, Portugal, Russia, Serbia, Spain, Singapore, Switzerland, Thailand, Taiwan, Turkey, Ukraine and the UK (NCT02075840)
  • 14 Sep 2017 Launched for Non-small cell lung cancer (Diagnosis) in China before September 2017(unspecified route)
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