Netherlands-based Qiagen has received US Food and Drug Administration (FDA) approval under a full premarket approval (PMA) for its artus CMV RGQ MDx Kit for human cytomegalovirus (CMV).
The company said that the test is the only FDA-approved PCR-based assay optimised for low to mid-throughput testing of CMV.
Compared with other PMA approved tests, the assay provides faster results with a turn-around time of three hours.
artus CMV RGQ MDx runs on the company’s Rotor-Gene Q MDx real-time PCR platform, which was cleared by the FDA in 2012.
Qiagen chief executive officer Peer Schatz said: "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.
"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 US 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 mainly used as an aid in the management of solid organ transplant patients to evaluate viral load in response to antiviral drug therapy.
According to the company, these patients are at high risk of life-threatening CMV infections in the months after surgery, and antiviral drug treatment is standard.
Between 20% and 60% of all transplant patients, depending on patient and procedure, are repeatedly tested for CMV throughout the first year after transplantation, the company said.