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Premarket Approval (PMA)
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DeviceQuest Diagnostics AAVrh74 Antibody ELISA CDx
Generic NameAssays to detect pre-existing antibodies to adeno-associated virus (AAV) viral vectors
ApplicantQuest Diagnostics Nichols Institute
33608 Ortega Highway
San Juan Capistrano, CA 92675
PMA NumberP250002
Date Received01/27/2025
Decision Date07/24/2025
Product Code QWQ 
Advisory Committee Hematology
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedYes
Approval Order 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.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
Labeling
Labeling Part 2
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