Sam Brusco, Associate Editor05.10.22
Hologic has earned U.S. Food and Drug Administration (FDA) approval for its Aptima CMV Quant assay to quantify viral load of cytomegalovirus (CMV) in solid organ or stem cell transplant patients.
It’s the company’s first test in the U.S. for post-transplant pathogen detection and monitoring on its Panther system, joining the existing arsenal of diagnostic and viral load testing for HIV-1, hepatitis C, and hepatitis B.
“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,” Michelle Garsha, Hologic’s president of Diagnostic Solutions told the press. “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 usually causes mild or asymptomatic infections in those with healthy immune systems. Transplant patients, however, are artificially immunosuppressed to prevent transplant rejection, making them more vulnerable to infections. If left untreated, CMV infection in these patients can cause severe disease, transplant rejection, or even death.
“It is imperative to have highly accurate, reproducible results to monitor viral load trends of CMV infections over time in plasma of transplant patients,” said Karen Harrington, Ph.D., Head of Scientific Affairs for Diagnostic Solutions at Hologic. “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.”
The assay is also CE marked for diagnostic and viral load monitoring. Hologic aims to pursue regulatory approvals for other transplant assays currently in development, including BK Virus and Epstein-Barr Virus.
It’s the company’s first test in the U.S. for post-transplant pathogen detection and monitoring on its Panther system, joining the existing arsenal of diagnostic and viral load testing for HIV-1, hepatitis C, and hepatitis B.
“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,” Michelle Garsha, Hologic’s president of Diagnostic Solutions told the press. “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 usually causes mild or asymptomatic infections in those with healthy immune systems. Transplant patients, however, are artificially immunosuppressed to prevent transplant rejection, making them more vulnerable to infections. If left untreated, CMV infection in these patients can cause severe disease, transplant rejection, or even death.
“It is imperative to have highly accurate, reproducible results to monitor viral load trends of CMV infections over time in plasma of transplant patients,” said Karen Harrington, Ph.D., Head of Scientific Affairs for Diagnostic Solutions at Hologic. “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.”
The assay is also CE marked for diagnostic and viral load monitoring. Hologic aims to pursue regulatory approvals for other transplant assays currently in development, including BK Virus and Epstein-Barr Virus.