Research & Development
Hologic Receives FDA Approval of Aptima CMV Quant Assay for Human Cytomegalovirus
12 May 2022 - - The US Food and Drug Administration approved US-based Hologic, Inc's (NASDAQ: HOLX) Aptima CMV Quant assay to quantify the viral load of cytomegalovirus in patients who have had solid organ or stem cell transplants, the company said.

The test is the first to be introduced in the US 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. Learn more about Aptima virology assays.

The Panther system for molecular diagnostics is a best-in-class fully automated, sample-to-result platform with adaptable workflow options and consolidated testing menu.

The Panther Fusion system provides an expanded in-vitro diagnostics menu, as well as Open Access functionality to run laboratory-developed tests. Hologic's Panther and Panther Fusion systems now offer 19 FDA-cleared, approved, and authorized assays and up to 21 assays outside the US depending on the region.

This high-throughput molecular diagnostic platform combines comprehensive sexual health, cervical health, viral load, respiratory testing and open channel functionality on a fully automated system.

Hologic is an innovative medical technology company primarily focused on improving women's health and well-being through early detection and treatment.