Quest Diagnostics Launches Simplexa(TM) Dengue Test in Brazil, First Commercial Molecular Test Approved for Nation’s Public and Private Health Testing
MADISON, N.J. and CYPRESS, Calif., Dec. 6, 2011 /PRNewswire/ — Quest Diagnostics Incorporated (NYSE: DGX), the world’s leading provider of diagnostic testing, information and services, today announced that the Simplexa(TM) Dengue molecular test kit developed by its Focus Diagnostics products business has been registered for distribution in Brazil. The test kit, from the award-winning Simplexa product line on the 3M(TM) Integrated Cycler, is the first commercial real-time polymerase chain reaction (RT-PCR) test to be approved for use by Brazil’s public and private health laboratories for testing for Dengue viruses.
In Brazil, only test kits registered with the National Agency of Sanitary Vigilance, an office of Brazil’s federal government, can be used by public or private health labs for clinical testing of patient specimens. Major public reference and private laboratories in the country are now evaluating the test for use on patient specimens.
Dengue, a virus transmitted by the Aedes mosquito, is endemic throughout the tropics and subtropics. Brazil has the greatest number of dengue infections in the Americas, with nearly a million cases annually accounting for 60 percent of the region’s dengue infections.
“Dengue is a major source of illness in Brazil and a burden on the country’s healthcare system,” said John G. Hurrell, Ph.D., vice president and general manager, Focus Diagnostics. “Public health and private clinicians in Brazil now have, for the first time, a registered commercial molecular-based tool for testing specimens in their own molecular laboratories. A reliable solution that can quickly identify patients with primary or secondary dengue infections will help physicians improve clinical management of patients in dengue-endemic areas.”
Simplexa tests on the 3M(TM) Integrated Cycler employ RT-PCR to qualitatively and quantitatively detect viruses, bacteria and other agents. The Dengue test is performed on whole blood specimens to quantitatively detect and differentiate between the four Dengue serotypes (viruses DEN1-4). Results can be provided in as few as 60 minutes following sample extraction.
Dengue symptoms range from mild fever to severe headaches with muscle and joint pain. Dengue hemorrhagic fever is a potentially fatal complication primarily affecting children. Although there are no specific antiviral medicines for Dengue, “early clinical diagnosis and careful clinical management by experienced physicians and nurses increase survival of patients,” according to the World Health Organization (WHO). The use of RT-PCR for dengue detection and differentiation allows clinicians to identify the presence of the virus, potentially enhancing clinical outcomes.
Up to 50 million dengue infections occur worldwide every year, according to estimates by the WHO.
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(TM). 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, CMV, 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.
To learn more about or to order Simplexa and other Focus Diagnostics tests, please contact Focus Diagnostics at 800-445-0185 (U.S.) or +49-6026-9499540 (Europe), or visit SimplexaDx.com or FocusDx.com.
About Quest Diagnostics
Quest Diagnostics is the world’s leading provider of diagnostic testing, information and services that patients and doctors need to make better healthcare decisions. The company offers the broadest access to diagnostic testing services through its network of laboratories and patient service centers, and provides interpretive consultation through its extensive medical and scientific staff. Quest Diagnostics is a pioneer in developing innovative diagnostic tests and advanced healthcare information technology solutions that help improve patient care. Additional company information is available at QuestDiagnostics.com. Follow us at Facebook.com/QuestDiagnostics and Twitter.com/QuestDX.
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SOURCE Quest Diagnostics Incorporated