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: 28 Jul 2017

$50 / €47 *
* $ price applies to USA, Canada and Latin America. € price applies to the rest of the world. Final gross prices may vary according to local VAT.

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

  • 25 Jul 2017 Roche obtains CE mark for VENTANA ALK (D5F3) CDx Assay as a companion diagnostic for ceritinib in Non-small cell lung cancer (Diagnosis; ALK-positive)
  • 01 Jun 2017 The US FDA approves VENTANA ALK (D5F3) CDx Assay as a companion diagnostic for ceritinib in Non-small cell lung cancer (Diagnosis; ALK-positive) in USA
  • 07 Nov 2016 The US FDA approves ALK IHC companion diagnostic for crizotinib for use on the VENTANA BenchMark ULTRA automated slide stainer in USA
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