Quest Diagnostics granted FDA breakthrough designation for AAV test

Quest Diagnostics has announced that its AAVrh74 ELISA (CDx) has been granted Breakthrough Device Designation from the US Food and Drug Administration (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 (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’ ELEVIDYS (delandistrogene moxeparvovec-rokl) gene therapy for certain individuals with Duchenne muscular dystrophy (DMD).

In addition, Quest and Sarepta, the leader in precision genetic medicine for rare diseases, have 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 FDA approval in June 2023. Quest will also provide clinical laboratory testing for Sarepta.

"Achieving ‘Breakthrough’ designation for our AAVrh74 ELISA, and collaboration with AAV-gene therapy pioneer Sarepta, positions Quest at the forefront of companion diagnostics innovation in the growing field of gene therapies," said Bill Finger, General Manager, Pharma Services, Quest Diagnostics. "Our AAV testing expertise has the potential to empower many life science collaborators to develop, and ultimately bring to market, companion diagnostics for their gene therapies."


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