HLA

BiomarkerHLA Typing

Human leukocyte antigen (HLA) genes regulate immune recognition. Specific HLA types are required for eligibility for certain cell-based and immune therapies.

Approvals
2
Indications
2
Therapies
2
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 HLA is defined directly in the indication labeling.

IndicationBiomarker criteriaTherapies
Synovial sarcoma
Solid Tumor · Soft Tissue
  • Eligible alleles: HLA-A*02:01, HLA-A*02:02, HLA-A*02:03 or HLA-A*02:06 and their P-group alleles. Exclusion alleles: HLA-A*02:05 and its P-group alleles.
Uveal Melanoma
Solid Tumor · Eye
  • HLA-A*02:01
Tumor-agnostic approvals

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

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

Tests that measure this biomarker

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

Test
SeCore CDx HLA Sequencing System
One Lambda, Inc.
Method
SANGER
Specimen
Whole blood

Reports HLA as part of its biomarker panel.

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