Hologic receives European approval for viral test sales
Photo | Grant Welker
Hologic's Marlborough headquarters
Marlborough medical technology company Hologic has been granted European approval for an assay quantifying the viral load of human cytomegalovirus in a patient.
In a press release announcing the CE Mark approval, as European health regulations are known, the company said its Aptima CMV Quant assay is intended for use to aid in the diagnosis and management of solid-organ transplant patients and hematopoietic stem cell transplant patients. These patients must have levels of CMV monitored, according to the company.
“Immunocompromised patients are vulnerable to a range of infections, with CMV a frequent complication, and healthcare providers need to quantify and monitor CMV accurately,” Jan Verstreken, international group president for Hologic, said in a release.
Human CMV is a common DNA virus belonging to the herpes family, according to Hologic, with infections 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.
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