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Quest Diagnostics Says FDA Grants Breakthrough Designation For Adeno-associated Virus Test

Por: RTTNews Health August 30, 2023

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Quest Diagnostics (), a diagnostic information services provider, announced Wednesday 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... + full article



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