US-based medical technology company Hologic has secured approval from the US Food and Drug Administration (FDA) for its Aptima CMV Quant assay.
The test was approved to quantify the viral load of cytomegalovirus (CMV) in patients who underwent solid organ or stem cell transplants.
CMV is a common virus and does not usually cause illness in healthy people.
However, CMV infection can turn serious among transplant recipients, who are typically treated with immunosuppressants to prevent transplant rejection.
The newly approved Aptima CMV Quant assay will help in post-transplant pathogen detection and improve patient outcomes. It also expands the company’s existing portfolio of diagnostic and viral load testing for HIV-1, Hepatitis C and Hepatitis B.
Hologic scientific affairs for 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.”
The Aptima CMV Quant assay has already obtained CE mark for diagnostic and viral load monitoring in Europe.
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.”
Last year, Hologic acquired surgical instrument manufacturer Bolder Surgical.