FDA clears Hologic's assay for human cytomegalovirus

By LabPulse.com staff writers

May 12, 2022 -- The U.S. Food and Drug Administration (FDA) has cleared Hologic's Aptima CMV Quant assay for assessing cytomegalovirus viral load in patients getting transplants of solid organs or stem cells.

It is Hologic's first test to be available in the U.S. for identifying post-transplant pathogens using the company's automated Panther system. Aptima CMV Quant also has the CE Mark for diagnostic use and viral load testing in Europe, Hologic said.

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Last Updated bc 5/13/2022 2:47:23 PM