ROCTAVIAN (valoctocogene roxaparvovec-rvox)
TherapyBioMarin
ROCTAVIAN (valoctocogene roxaparvovec-rvox) from BioMarin is a gene therapy indicated for adults with severe hemophilia A.
Approvals
1
Indications
1
Biomarkers
1
Mapped tests
1
Where this therapy is approved with a companion diagnostic
Each row represents a defined combination of indication, biomarker criteria, and ROCTAVIAN. Select a testing pathway to see the eligible companion diagnostic tests.
Indication-specific approvals
Approvals where ROCTAVIAN is tied to a specific indication and biomarker definition.
| Indication | Biomarker criteria | Notes | |
|---|---|---|---|
Hemophilia A Patients Non-cancer · Blood | AAV Antibodies
| View testing pathway → |
Tumor-agnostic approvals
Approvals defined at the solid tumor level where biomarker criteria determine eligibility for ROCTAVIAN.
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 ROCTAVIAN for eligible patients.
Test
AAV5 DetectCDx
ARUP Laboratories, Inc.
Method
AAV_Antibody
Specimen
Plasma
1 approvalView test profile →