Hologic Receives European CE Mark for Molecular Assay to Quantify Human Cytomegalovirus

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Hologic, Inc. has received CE mark for its new Aptima® CMV Quant assay in Europe, the Company announced. This assay, which quantifies the viral load of human cytomegalovirus (CMV), is intended for use to aid in the diagnosis and management of solid-organ transplant patients and hematopoietic stem cell transplant patients. This in vitro nucleic acid amplification test (NAAT) uses real-time transcription-mediated amplification (TMA) technology on the fully automated Panther® system and can be used with human plasma and whole blood samples.

“Immunocompromised patients are vulnerable to a range of infections, with CMV a frequent complication, and healthcare providers need to quantify and monitor CMV accurately,” said Jan Verstreken, group president, International. “Our Aptima CMV Quant assay is the first in a new line of Hologic assays for transplant patients and demonstrates our commitment to our laboratory partners to expand our molecular diagnostics business into new segments.”

Human CMV is a common DNA virus that belongs to the herpes family. Its prevalence in the population ranges from 45 to 100% worldwide.1,2 CMV infections are typically mild or asymptomatic in people with normal immune systems. However, in immunocompromised people such as transplant recipients, CMV is a common cause of morbidity and mortality. CMV, like other herpes viruses, may cause a lifelong latent infection that can sporadically reactivate. In transplant recipients, transfer of latent CMV in the graft or reactivation of latent CMV infection in the host may result in widespread viral replication and dissemination to multiple organs, which is often life-threatening.

As higher viral loads generally correlate to an increased risk of CMV disease,3,4 it is crucial that CMV levels are quantitated in transplant patients, in conjunction with monitoring clinical presentation and other laboratory markers. Recent guidelines recommend at least weekly monitoring of CMV viral load post-transplant to guide decisions about starting anti-CMV therapy as well as to monitor response to therapy.

About Hologic

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