Subject: FDA
QIAGEN receives U.S. FDA approval for cytomegalovirus (CMV) testing on automated QIAsymphony platform
GERMANTOWN, Md. and HILDEN, Germany, June 6, 2017 /PRNewswire/ -- 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.
Among organ transplant patients, an estimated 40-70% of post-transplant mortality is linked to higher susceptibility to opportunistic infections such as CMV. Timely and accurate monitoring of CMV viral load through a molecular test such as the artus CMV assay is essential to monitoring these patients, and in particular for those undergoing antiviral drug therapy for a CMV infection. The U.S. market for annual CMV testing is estimated at about 1.1 million tests, and QIAGEN is a leader in transplant-related molecular testing on a global scale and supported by a strong market presence in the U.S.
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SOURCE QIAGEN
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