Erlotinib companion diagnostic - Roche Diagnostics

Drug Profile

Erlotinib companion diagnostic - Roche Diagnostics

Alternative Names: cobas EGFR Mutation Test v2; cobasEGFR Mutation Test

Latest Information Update: 03 Jun 2016

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At a glance

  • Originator Roche Diagnostics
  • Class Diagnostic agents
  • 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

  • 01 Jun 2016 US FDA approves Erlotinib companion diagnostic for use with plasma samples for Non-small cell lung cancer (Diagnosis) in USA
  • 13 Nov 2015 The US FDA approves cobas® EGFR Mutation Test v2 for use with tumours samples for Non-small cell lung cancer (diagnosis) in USA
  • 14 May 2013 Registered for Non-small cell lung cancer (diagnosis) in USA
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