Quest Diagnostics earns FDA breakthrough designation for adeno-associated virus test

Quest Diagnostics was recently granted a breakthrough device designation from the FDA for its adeno-associated virus test. 

The test is intended to help identify patients eligible for treatment with Sarepta Therapeutics' ELEVIDYS gene therapy for individuals with Duchenne muscular dystrophy, according to an Aug. 30 news release.

Quest also announced its collaboration with Sarepta to develop other diagnostics to complement Sarepta's gene therapies. It will also provide clinical lab testing for Sarepta.

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