The world's leading provider of diagnostic testing, Quest Diagnostics Incorporated, reported that its Focus Diagnostics business has CE marked its new Simplexa Cytomegalovirus (CMV) molecular test kit on the 3M Integrated Cycler for distribution to approximately 35 countries in Europe.
The test is designed to enable hospital labs to perform advanced molecular testing for cytomegalovirus (CMV), a potentially fatal virus infection in patients with compromised immunity, particularly those undergoing organ transplantation.
Focus Diagnostics will showcase the Simplexa CMV and other Simplexa tests at the Medica 2011 International Trade Fair with Congress – World Forum for Medicine, to be held November 16-19, 2011, in Dusseldorf, Germany.
The Simplexa CMV test employs real-time polymerase chain reaction to quantitatively detect CMV in whole blood specimens and plasma. With the CE mark of the Simplexa CMV test, Focus Diagnostics has one of the most comprehensive molecular transplant-testing menus in the European marketplace. In early 2011, Simplexa EBV and Simplexa BK quantitative assays were granted CE-IVD status. Focus Diagnostics also offers molecular primer pairs for the development of laboratory tests, including JC virus, Varicella-Zoster Virus (VZV), adenovirus and human herpesvirus-6 (HHV-6).
"The ability to detect and quantify CMV and other viruses known to affect organ transplant and other immunocompromised patients is critical to patient care," said Jay M. Lieberman, M.D., medical director, infectious disease, Quest Diagnostics and Focus Diagnostics. "With our Simplexa CMV and other test products, physicians in hospitals and other facilities with molecular labs can more quickly get the laboratory results they need to manage their at-risk patients and avoid potentially life-threatening complications."
As with other members of the herpes virus family, CMV is typically latent after primary infection. It can reactivate when the immune system is significantly weakened, such as following 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.
Focus Diagnostics, a wholly-owned business of Quest Diagnostics, develops and manufactures the Simplexa line of molecular test products operating on the 3M Integrated Cycler, a compact, portable testing platform, as part of an exclusive global collaboration with 3M. Simplexa was the first test kit to be FDA cleared for aiding in the detection and differentiation of the 2009 H1N1 influenza virus, in May 2010. Additional FDA-cleared Simplexa tests aid the detection of influenza A and B and respiratory syncytial virus. Several other Simplexa-branded tests, including for Clostridium difficile, Epstein Barr and BK viruses, are CE marked and distributed in Europe. In 2011, the Simplexa/3M technology won a gold Medical Design Excellence Award in the in vitro diagnostics category and an Edison Award for new science and medical diagnostic product.