Quest Diagnostics granted FDA Breakthrough Designation for its Adeno-associated virus (AAV) test

Sept. 5, 2023
Quest and Sarepta Therapeutics expand collaboration to develop AAV companion diagnostics (CDx) for Sarepta's Gene Therapies.

Quest Diagnostics announced that its AAVrh74 ELISA assay (CDx) has been granted Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA).

The enzyme-linked immunosorbent in vitro diagnostic assay is for the semi-quantitative detection of antibodies (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, Inc.'s (NASDAQ: 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. The collaboration may encompass screening assays for antibodies to Sarepta's AAV-vector based gene therapies for muscular dystrophies, including Duchenne muscular dystrophy (DMD) and limb girdle muscular dystrophies (LGMD). The first companion diagnostic will be for Sarepta's first gene therapy, ELEVIDYS (delandistrogene moxeparvovec-rokl), intended to treat the underlying genetic cause of DMD, which received U.S. Food and Drug Administration approval in June 2023. Quest will also provide clinical lab testing for Sarepta.

Quest release