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AAV Antibodies

Biomarker

Adeno-associated virus (AAV) antibodies reflect prior exposure to AAV vectors and can impact eligibility and efficacy of gene therapies that use AAV-based delivery. Pre-existing antibodies may neutralize the vector and are commonly assessed before treatment.

Approvals
3
Indications
3
Therapies
3
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 AAV Antibodies is defined directly in the indication labeling.

IndicationBiomarker criteriaTherapies
Duchenne Muscular Dystrophy (DMD)
Other · Muscle
  • serotype rh74
Hemophilia A Patients
Other · Blood
  • serotype 5
Moderate to severe Hemophilia B patients
Other · Blood
  • serotype rh74
Tumor-agnostic approvals

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

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

Tests that measure this biomarker

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

Test
AAV5 DetectCDx
ARUP Laboratories, Inc.
Method
AAV_Antibody
Specimen
Plasma

Reports AAV Antibodies as part of its biomarker panel.

Test
nAbCyte Anti-AAVRh74var HB-FE Assay
Labcorp
Method
AAV_Antibody
Specimen
Serum

Reports AAV Antibodies as part of its biomarker panel.

Test
Quest Diagnostics AAVrh74 Antibody ELISA CDx
Quest Diagnostics
Method
AAV_Antibody
Specimen
Serum

Reports AAV Antibodies as part of its biomarker panel.

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