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Hologic Receives CE Mark for Molecular Test to Quantify Cytomegalovirus

NEW YORK ─ Marlborough, Massachusetts-based Hologic said on Wednesday that it has received the CE mark for its Aptima CMV Quant assay, making it available in Europe and other regions that accept the designation.

The assay quantifies the viral load of human cytomegalovirus to help diagnose and manage solid-organ transplant patients and hematopoietic stem cell transplant patients. It uses plasma and whole blood samples as well as real-time transcription-mediated amplification technology while running on Hologic's fully automated Panther system.

"Immunocompromised patients are vulnerable to a range of infections, with CMV [being] a frequent complication, and healthcare providers need to quantify and monitor CMV accurately," Jan Verstreken, group president, international, at Hologic, said in a statement.

The Aptima CMV Quant assay is the first in a new line of Hologic assays for transplant patients and demonstrates the firm's commitment to expand its molecular diagnostics business into new segments, Verstreken added.