Quest Diagnostics Granted FDA Breakthrough Designation for its Adeno-associated virus (AAV) Test
On August 30, 2023, Quest Diagnostics announced that its AAVrh74 ELISA assay (CDx) has been granted Breakthrough Device Designation from the US Food and Drug Administration (FDA).
The enzyme-linked immunosorbent in vitro diagnostic technique is used to detect antibodies (IgG) to the AAVrh74 capsid in human serum in a semi-quantitative manner. The test is intended to be used in conjunction with other clinical data as a tool to help identify patients who are qualified to receive treatment with ELEVIDYS (delandistrogene moxeparvovec-rokl), a gene therapy for some ...