QIAGEN (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced it has received premarket approval from the U.S. Food and Drug Administration (FDA) for its automated artus® CMV QS-RGQ MDx kit for use on QIAGEN’s QIAsymphony platform, providing fast, reproducible, high-quality test results for use as an aid in the management of solid organ transplant patients who are undergoing anti-CMV therapy.
Patients who have undergone organ transplantation have an elevated risk of infection from CMV, which is a common virus that infects people of all ages. Over half of all adults by age 40 have been infected with CMV, according to the U.S. Centers for Disease Control (CDC). Once CMV is in a person’s body, it stays there for life in latent form and can reactivate.