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t(9;21) Philadelphia chromosome

Biomarker

The Philadelphia chromosome results from a chromosomal translocation creating an oncogenic fusion. It is a defining feature in certain leukemias and guides targeted therapy.

Approvals
1
Indications
1
Therapies
1
Mapped tests
1

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 t(9;21) Philadelphia chromosome is defined directly in the indication labeling.

IndicationBiomarker criteriaTherapies
Chronic Myeloid Leukemia (CML)
Heme · Leukemia
  • BCR-ABL fusion
Tumor-agnostic approvals

Approvals defined at the solid tumor level where t(9;21) Philadelphia chromosome is part of the eligibility criteria.

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

Tests that measure this biomarker

These assays report t(9;21) Philadelphia chromosome as part of their validated menu. In many cases they are identified in FDA labeling as acceptable companion diagnostics for specific approvals.

Test
MRDx BCR-ABL Test
MolecularMD Corporation
Method
PCR
Specimen
Whole blood

Reports t(9;21) Philadelphia chromosome as part of its biomarker panel.

This view is scoped to t(9;21) Philadelphia chromosome. You can also see how it compares with other biomarkers and indications on the Know Your Companions™ map.