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Qiagen CMV Assay Wins FDA Approval

NEW YORK (GenomeWeb) — Qiagen said Wednesday after the close of the market that its artus CMV RGQ MDx kit for human cytomegalovirus has been approved by the US Food and Drug Administration under a full premarket approval.

The test runs on Qiagen's Rotor-Gene Q MDx real-time PCR platform, which was cleared by the FDA in 2012 and is part of the QIAsymphony family of modular, automated instruments.

The new assay is designed to quantify cytomegalovirus viral load in organ transplant patients in about three hours, and is the only FDA-approved PCR-based assay optimized for low- to mid-throughput CMV testing, Qiagen said.

CMV testing is primarily used to aid in the management of solid organ transplant patients to assess viral load in response to antiviral drug therapy. These patients are at high risk of life-threatening CMV infections in the months following surgery, and antiviral drug treatment is standard. Qiagen said that between 20 percent and 60 percent of all transplant patients are repeatedly tested for CMV throughout the first year following transplantation.

"In addition to helping save lives with its clinically proven usefulness, the FDA-approved artus test creates economic value by reducing the time and money many labs and hospitals currently must spend validating lab-developed CMV tests and analyte-specific reagents," Qiagen CEO Peer Schatz said in a statement. "More than one million CMV tests are performed on US transplant patients each year and we believe the artus CMV kit will provide significant value for laboratories, patients, and the healthcare system."

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