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ALK IHC companion diagnostic - Roche Tissue Diagnostics

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Drug Profile

ALK IHC companion diagnostic - Roche Tissue Diagnostics

Alternative Names: Alectinib companion diagnostic - Roche Tissue Diagnostics; ALK gene rearrangement diagnostic - Roche Tissue Diagnostics; Crizotinib companion diagnostic - Roche Tissue Diagnostics; RG 7853 companion diagnostic - Roche Tissue Diagnostics; VENTANA ALK (D5F3) CDx Assay; VENTANA ALK IHC diagnostic test

Latest Information Update: 04 Feb 2026

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At a glance

  • Originator Ventana Medical Systems
  • Developer Roche; Roche Tissue Diagnostics
  • 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

  • 04 Feb 2026 Phase-III clinical trials in Non-small cell lung cancer (Diagnosis) is still ongoing in Russia, Turkey, Ukraine, Serbia (unspecified route) (NCT02075840)
  • 13 Jul 2021 Ventana Medical Systems is now called Roche Tissue Diagnostics
  • 09 Mar 2021 The US FDA approves the VENTANA ALK (D5F3) CDx Assay as a companion diagnostic for ALK-positive Non-small cell lung cancer eligible for treatment with lorlatinib (Diagnosis) in USA

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