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: 10 Nov 2016

Price : $50

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.

  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

  • New Molecular Entity No

Highest Development Phases

  • Marketed Non-small cell lung cancer

Most Recent Events

  • 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
  • 15 Jun 2015 Registered for Non-small cell lung cancer (Diagnosis) in USA (unspecified route)
  • 12 Feb 2015 Ventana Medical Systems initiates enrolment in a phase III trial in Diagnostic tests in USA (NCT02075840)
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