Quest Diagnostics’ AAVrh74 ELISA assay receives Breakthrough Device Designation

Quest Diagnostics (DGX) announced that its AAVrh74 ELISA assay, or CDx, has been granted Breakthrough Device Designation from the FDA. Breakthrough Device Designation is an FDA process designed to expedite the development and review of certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The enzyme-linked immunosorbent in vitro diagnostic assay is for the semi-quantitative detection of antibodies, or IgG, to AAVrh74 capsid in human serum. The test is intended to be used in conjunction with other available clinical information as an aid to identify patients eligible for treatment with Sarepta Therapeutics’ (SRPT) ELEVIDYS (delandistrogene moxeparvovec-rokl), gene therapy for certain individuals with Duchenne muscular dystrophy. In addition, Quest and Sarepta announced an expanded collaboration under which Quest will develop one or more companion or complementary diagnostics in connection with Sarepta’s portfolio of investigational and on-market gene therapies.