ALK

Biomarker

ALK is a receptor tyrosine kinase that can be altered through gene rearrangements, mutations, or amplifications. ALK alterations are well-established oncogenic drivers in lung cancer and other malignancies and guide the use of targeted kinase inhibitors.

Approvals
12
Indications
1
Therapies
6
Mapped tests
4

Where this biomarker is used

Each approval combines this biomarker with a specific indication and therapy. Select a therapy in the tables below to open its FDA-defined testing pathway.

Indication-specific approvals

Approvals where ALK is defined directly in the indication labeling.

IndicationBiomarker criteriaTherapies
Non-Small Cell Lung Cancer (NSCLC)
Solid Tumor · Lung
  • gene rearrangements
  • protein expression
Tumor-agnostic approvals

Approvals defined at the solid tumor level where ALK is part of the eligibility criteria.

No tumor-agnostic approvals are currently mapped for this biomarker.

Tests that measure this biomarker

These assays report ALK as part of their validated menu. In many cases they are identified in FDA labeling as acceptable companion diagnostics for specific approvals.

Test
FoundationOne CDx
Foundation Medicine, Inc.
Method
NGS
Specimen
Tissue (FFPE)

Reports ALK as part of its biomarker panel.

Test
FoundationOne Liquid CDx
Foundation Medicine, Inc.
Method
NGS
Specimen
Whole blood

Reports ALK as part of its biomarker panel.

Test
Ventana ALK (D5F3) CDx Assay
Ventana Medical Systems, Inc.
Method
IHC
Specimen
Tissue (FFPE)

Reports ALK as part of its biomarker panel.

Test
Vysis ALK Break Apart FISH Probe Kit
Abbott Molecular, Inc.
Method
FISH
Specimen
Tissue (FFPE)

Reports ALK as part of its biomarker panel.

This view is scoped to ALK. You can also see how it compares with other biomarkers and indications on the Know Your Companions™ map.
ALK Biomarker | CDxTests.com | CDx Tests