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ELEVIDYS (delandistrogene moxeparvovec-rokl)

TherapySarepta Therapeutics

ELEVIDYS (delandistrogene moxeparvovec-rokl) from Sarepta Therapeutics is a gene therapy used in Duchenne muscular dystrophy.

Approvals

Indications

Biomarkers

Mapped tests

Where this therapy is approved with a companion diagnostic

Each row represents a defined combination of indication, biomarker criteria, and ELEVIDYS. Select a testing pathway to see the eligible companion diagnostic tests.

Indication-specific approvals

Approvals where ELEVIDYS is tied to a specific indication and biomarker definition.

Indication	Biomarker criteria	Notes
Duchenne Muscular Dystrophy (DMD) Non-cancer · Muscle	AAV Antibodies serotype rh74		View testing pathway →

Tumor-agnostic approvals

Approvals defined at the solid tumor level where biomarker criteria determine eligibility for ELEVIDYS.

No tumor-agnostic companion diagnostic approvals are currently mapped for this therapy.

Tests used in these approvals

These assays are identified in FDA labeling or sponsor materials as companion diagnostics or acceptable tests when considering ELEVIDYS for eligible patients.

Test

Quest Diagnostics AAVrh74 Antibody ELISA CDx

Quest Diagnostics

Method

AAV_Antibody

Specimen

Serum

1 approvalView test profile →

This view is scoped to ELEVIDYS (delandistrogene moxeparvovec-rokl). You can also see how it compares with other therapies and indications on the main Know Your Companions™ map.