CE Marks for Simplexa™ Tests for Epstein Barr and BK Viruses

Two new Simplexa-branded molecular test kits developed by Focus Diagnostics a business unit of Quest Diagnostics Inc., have been CE marked for distribution to approximately 35 countries in Europe. The test kits, designed to enable hospital labs to perform advanced molecular testing for Epstein-Barr (EBV) and BK viruses, are the first products from the award-winning Simplexa line to aid in the clinical management of patients with compromised immunity.

Simplexa tests, running on the 3M™ Integrated Cycler, employ real-time polymerase chain reaction (RT-PCR) diagnostic technologies to qualitatively and quantitatively detect viruses, bacteria and other agents. The EBV test is performed on whole blood specimens and the BK virus test is performed on either urine or plasma specimens to quantitatively detect the viruses.

'Infection with EBV or BK virus poses a major health threat to certain immunocompromised patients, such as those who have recently undergone organ transplantation,' said Jay M. Lieberman, M.D., medical director for Quest Diagnostics and Focus Diagnostics. 'Detecting these viruses, and being able to quantify the amount of the virus present, is critical to monitor and evaluate at-risk patients. Our Simplexa tests provide physicians with vital information to help them manage potentially life-threatening complications.'

Most healthy people are infected with EBV, the cause of mononucleosis, and BK virus at some point during their lives. After the primary infection, which may or may not be associated with symptoms, the viruses typically become 'latent' or quiet in the body. However, the viruses can reactivate when the immune system is significantly weakened, for example after organ transplantation, and cause fever, organ rejection and even death.
Europe represents the largest organ transplantation market in the world, with an estimated 31,379 organ transplant procedures performed in 2010, according to an analysis by Global Industry Analysis, Inc.¹

'The success of solid organ transplantation can hinge on how well a physician detects and prevents complications from infectious diseases like EBV and BK,' said John G Hurrell, Ph.D., vice president and general manager, Focus Diagnostics. 'CE marking of our new Simplexa EBV and BK virus tests will enable hospital and other labs in Europe to generate reliable results quickly in their own labs, an important advantage for managing these patients.'
Focus Diagnostics launched the Simplexa molecular product line in 2009 with a focus on influenza and respiratory syncytial virus. Simplexa was the first test kit to be FDA cleared for aiding the detection and differentiation of the 2009 H1N1 virus, in May 2010. The tests run on the 3M Integrated Cycler, a compact, portable testing platform that can provide results in as few as 60 minutes following sample extraction, as part of an exclusive worldwide agreement with 3M.