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Hologic Nabs FDA Approval for Quantitative Cytomegalovirus Test

May 10, 2022 | staff reporter

NEW YORK – Hologic announced on Tuesday that its Aptima CMV Quant assay for cytomegalovirus has been approved by the US Food and Drug Administration. 

The test uses plasma and whole-blood samples to quantify the viral load of cytomegalovirus in patients who have had solid organ or stem cell transplants. It runs on Hologic's fully automated Panther platform and is intended to be used for post-transplant pathogen detection and monitoring. 

The test "is the first in a series of planned quantitative assays to support patient care following transplant surgery," Michelle Garsha, president of diagnostic solutions at Hologic, said in a statement. Other transplant tests in development include assays for Epstein-Barr virus and BK virus. 

The CMV test "aligns with the international quantitative standards" for CMV monitoring, Karen Harrington, head of scientific affairs for diagnostic solutions at the company, added.

The Aptima CMV Quant test received CE marking in June 2021, and the Marlborough, Massachusetts-based company intends to pursue regulatory approvals for the other transplant tests in development, it said. 

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Regulatory News & FDA Approvals
Molecular Diagnostics
Infectious Disease
North America
FDA
cytomegalovirus
Hologic
regulatory approval
organ transplant
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