ROS1

Biomarker

ROS1 gene fusions drive oncogenic signaling in lung and other cancers. These alterations predict response to ROS1-targeted therapies.

Approvals
3
Indications
1
Therapies
2
Mapped tests
3

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 ROS1 is defined directly in the indication labeling.

IndicationBiomarker criteriaTherapies
Non-Small Cell Lung Cancer (NSCLC)
Solid Tumor · Lung
  • fusions
Tumor-agnostic approvals

Approvals defined at the solid tumor level where ROS1 is part of the eligibility criteria.

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

Tests that measure this biomarker

These assays report ROS1 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 ROS1 as part of its biomarker panel.

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

Reports ROS1 as part of its biomarker panel.

Test
Oncomine Dx Target Test
Life Technologies Corporation
Method
NGS
Specimen
Tissue (FFPE)

Reports ROS1 as part of its biomarker panel.

This view is scoped to ROS1. You can also see how it compares with other biomarkers and indications on the Know Your Companions™ map.