> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Breakthrough Designation for Quest Diagnostic
- URL: https://www.fdaweb.com/breakthrough-designation-for-quest-diagnostic/
- Published: 2023-08-30T12:00:00.000Z
- Updated: 2026-09-14T18:53:32.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5155218

FDA has granted Quest Diagnostics a breakthrough device designation for its AAVrh74 ELISA assay, an enzyme-linked immunosorbent *in vitro* diagnostic for the semi-quantitative detection of antibodies (IgG) to AAVrh74 capsid in human serum. The test is intended to be used as an aid to identify patients eligible for treatment with Sarepta Therapeutics’ Elevidys (delandistrogene moxeparvovec-rokl), a gene therapy for patients with Duchenne muscular dystrophy. Quest and Sarepta say they have recently expanded a collaboration under which Quest will develop one or more companion or complementary diagnostics in connection with Sarepta’s portfolio of investigational and approved gene therapies.