Cepheid Launches CE Mark Certification Smart CMV™ In Vitro Diagnostic Test for SmartCycler® Platform
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Cepheid has announced the European release of the Smart CMV™ (cytomegalovirus) Assay for clinical diagnostic use on the SmartCycler® System.
The CMV assay was released as a CE IVD Mark product under the European Directive on In Vitro Diagnostic Medical Devices.
Smart CMV is intended for detection and quantitation of CMV viral load. Detection of active CMV infection plays a critical role in diagnosis and treatment.
Periodic monitoring of CMV viral load in consecutive clinical samples is used to identify high-risk patients and to monitor their response to CMV therapy.
Because of their specificity and sensitivity, real-time PCR diagnostics like Smart CMV are an important tool in the effective clinical management of CMV patients.
"Cytomegalovirus (CMV) is an important pathogen in immunosuppressed patients, including organ transplant recipients and AIDS patients," said Professor Mario Poljak, MD, Ph.D., Head of the Laboratory for Molecular Microbiology and Head of Slovenian AIDS Reference Centre at the Medical Faculty of Ljubljana in Slovenia.
"The clinical utility of quantitative CMV DNA tests in managing these patient groups has been well documented."
"In transplant recipients, CMV load is used to diagnose active CMV disease, screen patients for the use of preemptive therapy, and monitor the response to antiviral therapy."
"In patients infected with human immunodeficiency virus type 1, the risk of developing CMV disease has been reported to be directly related to the quantity of CMV DNA in plasma."
"Smart CMV is the sixth in a planned menu of CE IVD Mark products launching into the European market this year, and the third product in our expanding portfolio for use in the management of immunocompromised patients," said Cepheid Chief Executive Officer John Bishop.
"Cepheid's scaleable SmartCycler® and GeneXpert® technologies are making it easier and cost effective for institutions of any size to reap the benefits of molecular diagnostics."
The SmartCycler® System is a real-time PCR testing platform for hospitals, university research labs and government agencies.
With up to 96 independently programmable reaction sites, the SmartCycler® System is designed to simultaneously run different tests with different protocols and at different times.