Hologic, Inc. announced that the U.S. Food and Drug Administration (FDA) approved its Aptima CMV Quant assay to quantify the viral load of cytomegalovirus (CMV) in patients who have had solid organ or stem cell transplants. The test is the first to be introduced in the U.S. by Hologic for post-transplant pathogen detection and monitoring on Hologic's fully automated Panther® system, and joins the existing portfolio of diagnostic and viral load testing for HIV-1, Hepatitis C and Hepatitis B. CMV is a common virus that typically causes mild or asymptomatic infections in people with healthy immune systems. However, transplant recipients typically are artificially immunosuppressed to prevent transplant rejection, which makes them more vulnerable to infections. If left untreated, CMV infection can lead to severe disease, transplant rejection and even death.

Guidelines from the American Society of Transplantation and the World Health Organization recommend CMV monitoring as standard of care to help guide treatment decisions for transplant patients, depending on their risk and transplant organ type. The Aptima CMV Quant assay also is CE-marked for diagnostic and viral load monitoring use in Europe. Hologic intends to pursue regulatory approvals for other transplant assays that are currently in development, including BK Virus and Epstein-Barr Virus.