UK FETAL MEDICINE FOUNDATION APPROVES DELFIA PRENATAL ASSAYS.PerkinElmer, Inc. (NYSE NYSE See: New York Stock Exchange : PKI (Public Key Infrastructure) A framework for creating a secure method for exchanging information based on public key cryptography. The foundation of a PKI is the certificate authority (CA), which issues digital certificates that authenticate the identity of ), Boston, Mass., leading provider of drug discovery, life science research and analytical solutions, has announced that its DELFIA DELFIA Dissociation-Enhanced Lanthanide Fluorescent Immunoassay (R) Xpress first trimester prenatal screening assays have been approved by the Fetal Medicine fetal medicine n. The branch of medicine that deals with the growth, development, care, and treatment of the fetus and with environmental factors that may harm the fetus. Foundation (FMF FMF 1. Familial Mediterranean fever 2. Fetal movement felt 3. Forced mid-expratory flow 4. Free molecular flow ), London, UK. The approval of the assays makes them available in Europe for FMF-certified laboratories and FMF-certified clinicians for the detection of Down Syndrome Down syndrome, congenital disorder characterized by mild to severe mental retardation, slow physical development, and characteristic physical features. Down syndrome affects about 1 in every 730 live births and occurs in all populations equally. . The Fetal Medicine Foundation is a registered charity that promotes research and training in fetal medicine. FMF is widely respected globally and has established a standard for first trimester screening which embraces the role of clinicians, laboratories and the assays that are used. FMF promotes first trimester screening for Down Syndrome through nuchal translucency nuchal translucency n. A radiologic sign that appears as a translucent spot on a fetal sonogram and indicates subcutaneous fluid in the nuchal region of a fetus. , or a combination of nuchal translucency and maternal serum biochemistry. The combination of nuchal translucency and assay of maternal serum free hCGB and PAPP-A PAPP-A Pregnancy-Associated Plasma Protein A improves the detection of affected fetuses. Extensive prospective studies have reported that for a 5 percent false positive rate, the detection rates of trisomy trisomy /tri·so·my/ (tri´so-me) the presence of an additional (third) chromosome of one type in an otherwise diploid cell (2n + 1). See also entries under syndrome. triso´mic tri·so·my n. 21 are 85-90 percent for combined screening compared to 75 percent for ultrasound alone. "This approval represents an important endorsement of PerkinElmer's DELFIA technology," said Dr. Peter Coggins, president of PerkinElmer Life and Analytical Sciences. "To be recognized by the Fetal Medicine Foundation means that PerkinElmer has successfully demonstrated our common commitment to prenatal screening, and that our assays meet their strict criteria to be used in FMF certified laboratories." The approval covers assays for PAPP-A and free hCGB run on PerkinElmer's DELFIA Xpress random access platform. The system is designed to meet the needs of clinics and laboratories for fast delivery of reliable test results. DELFIA is a heterogeneous time-resolved fluorometric assay method in which an enhancement step assures high sensitivity and wide response range. The company's DELFIA manual assays and AutoDELFIA batch automation assays were approved by FMF some time ago. To obtain FMF approval, PerkinElmer was required to provide clinical data to prove the clinical validity of the assays, to demonstrate a commitment to prenatal screening, and to provide evidence of the successful use of assays in respected international studies. PerkinElmer, Inc. is a global technology leader focused in the following businesses - Life and Analytical Sciences, Optoelectronics and Fluid Sciences. Combining operational excellence and technology expertise with an intimate understanding of our customers' needs, PerkinElmer provides products and services in health sciences and other advanced technology markets that require innovation, precision and reliability. The company serves customers in more than 125 countries, and is a component of the S&P 500 Index. For more information, visit http://www.perkinelmer.com or call 877-PKI-NYSE or 781/431-4306. |
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