Qiagen has announced that its artus CMV RGQ MDx Kit for human cytomegalovirus (CMV) has been approved by the US Food and Drug Administration (FDA) under a full premarket approval (PMA).
The test is the only FDA-approved PCR-based assay optimized for low- to mid-throughput testing of CMV. With a turn-around time of approximately three hours, the assay provides faster results than other PMA approved tests.
artus CMV RGQ MDx runs on Qiagen’s Rotor-Gene Q MDx real-time PCR platform, which was cleared by the FDA in 2012 and is a member of the QIAsymphony modular family of automated instruments.
Qiagen CEO Peer Schatz said that the company is very pleased to add yet another FDA approved diagnostic kit to its menu of FDA approved or cleared content for a core element of its flagship QIAsymphony modular family of automated instruments.
"This flexible platform is driving the dissemination of molecular diagnostics by delivering efficient, reliable workflows in low- to mid-throughput settings, which represent the largest market opportunity in terms of placements, Schatz added.
"Our artus CMV assay is the fastest test approved for quantifying CMV viral loads in organ transplant patients. 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.
"More than one million CMV tests are performed on U.S. transplant patients each year and we believe the artus CMV kit will provide significant value for laboratories, patients and the healthcare system."
CMV testing is primarily used as an aid in the management of solid organ transplant patients to assess viral load in response to antiviral drug therapy.