Hologic Gains FDA’s Premarket Approval for Its Aptima CMV Quant Assay

The FDA granted Hologic’s Aptima CMV Quant assay premarket approval for quantifying the viral load of cytomegalovirus in patients who have had solid organ or stem cell transplants.

The test for posttransplant pathogen detection and monitoring is the latest addition to the company’s portfolio of diagnostic and viral load tests, which also include HIV-1, Hepatitis C and Hepatitis B.

The Aptima CMV Quant assay has also received a CE mark certification in Europe.

The new assay is the first in a series of planned quantitative assays to support patient care following transplant surgery, the company said.