Quest Diagnostics Granted FDA Breakthrough Designation for its Adeno-associated virus (AAV) Test

Quest and Sarepta Therapeutics Expand Collaboration to Develop AAV Companion Diagnostics (CDx) for Sarepta's Gene Therapies

SECAUCUS, N.J. and CAMBRIDGE, Mass., Aug. 30, 2023 /PRNewswire/ -- Quest Diagnostics (NYSE: DGX), the nation's leading provider of diagnostic information services, today announced that its AAVrh74 ELISA assay (CDx) has been granted Breakthrough Device Designation from the U.S. 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.