Hologic Announces FDA Approval of Aptima CMV Quant Assay for Human Cytomegalovirus

In full transparency, the following press release was submitted to SOURCE media through its business wire service.

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MARLBOROUGH – Hologic, Inc. announced 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.

“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,” said Michelle Garsha, President, Diagnostic Solutions at Hologic. “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.”

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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.^1-2

“It is imperative to have highly accurate, reproducible results to monitor viral load trends of CMV infections over time in plasma of transplant patients,” says Karen Harrington, PhD, 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.”

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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.

Hologic, Inc. is an innovative medical technology company primarily focused on improving women’s health and well-being through early detection and treatment. The company has its headquarters in Marlborough.