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Home » FDA greenlights Hologic’s Aptima CMV Quant assay for transplant patients
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FDA greenlights Hologic’s Aptima CMV Quant assay for transplant patients

May 18, 2022
By Annette Boyle
Hologic Inc. received FDA premarket approval for its Aptima CMV Quant assay, which enables monitoring of viral loads of transplant patients with cytomegalovirus (CMV). While CMV typically poses little risk to adults with healthy immune systems, it can cause organ rejection and death in transplant patients if untreated. The assay gained a CE mark in June 2021.
BioWorld MedTech Regulatory U.S.

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