Hologic has received the US Food and Drug Administration (FDA) approval for its Aptima CMV Quant assay to quantify the viral load of cytomegalovirus (CMV) in patients who have undergone solid organ or stem cell transplants.
The test runs on Hologic’s Panther system, a fully automated molecular diagnostics platform with adaptable workflow options and a consolidated testing menu.
Aptima CMV Quant joins the company’s existing portfolio of diagnostic and viral load tests for HIV-1, Hepatitis C and Hepatitis B.
Also, it is the first test to be rolled out in the US for the detection and monitoring of post-transplant pathogen on Panther system, said the medical technology company.
Hologic diagnostic solutions president Michelle Garsha said: “We have a legacy of innovation in viral load testing, and our Aptima CMV Quant assay is the first in a series of planned quantitative assays to support patient care following transplant surgery.
“We’re committed to providing our laboratory partners with superior solutions that improve workflow efficiency, support provider and patient needs and address the challenges faced by today’s molecular lab.”
CMV is a common virus that causes mild or asymptomatic infections in healthy people.
Transplant recipients, who are artificially immunosuppressed to prevent transplant rejection, are more vulnerable to CMV infections, which may lead to severe disease, transplant rejection and even death.
Hologic has secured CE mark approval for Aptima CMV Quant assay to enable diagnostic and viral load monitoring in Europe.
It intends to pursue regulatory approvals for other transplant assays that are currently under development, including BK Virus and Epstein-Barr Virus.
Hologic diagnostic solutions head Karen Harrington said: “It is imperative to have highly accurate, reproducible results to monitor viral load trends of CMV infections over time in plasma of transplant patients.
“Our assay aligns with the international quantitative standards, offering laboratories and healthcare providers confidence in the results each and every time, ultimately helping to enhance patient management and outcomes.”
Hologic’s Panther Fusion system offers an expanded in-vitro diagnostics (IVD) menu, along with Open Access functionality to run laboratory-developed tests (LDTs).
The Panther and Panther Fusion systems offer 19 FDA-approved assays and up to 21 assays outside the US, based on the region.
The high-throughput molecular diagnostic platform is said to offer sexual health, cervical health, viral load, respiratory testing and open channel functionality.
