Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors
Basic Information
- Device Name
- Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors
- Trade Name
- Quest Diagnostics AAVrh74 Antibody ELISA CDx
- PMA Number
- P250002
- Device Class
- FDA Class 3
- Product Code
- QWQ
- Generic Name
- Assays to detect pre-existing antibodies to adeno-associated virus (AAV) viral vectors
- Medical Specialty
- Unknown
- Advisory Committee
- Hematology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- July 24, 2025
- Date Received
- January 27, 2025
- Expedited Review
- N
Advisory Committee Statement
Quest Diagnostics AAVrh74 Antibody ELISA CDx is an enzyme-linked immunosorbent in vitro diagnostic assay intended for the semi-quantitative detection of antibodies (IgG) to AAVrh74 capsid in human serum. The test reports an antibody titer, and a semi-quantitative interpretation of the test results derived from the antibody titer. Patients with an AAVrh74 antibody titer less than 1:400 are reported as not elevated for AAVrh74 antibody titers and may be eligible for treatment with the gene therapy. Patients with an AAVrh74 antibody titer greater than or equal to 1:400 are reported as elevated for AAVrh74 antibody titers and are ineligible for treatment with the gene therapy. The test is for prescription use only. The test is intended to be used in conjunction with other available clinical information as an aid to identify patients eligible for treatment with indicated gene therapies.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QWQ | Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors | FDA class 3 | Unknown |