The first detection of neonatal severe comprehensive immunodeficiency kit was approved by the FDA
Release date: 2014-12-23 The FDA recently approved PerkinElmer's EnLite Neonatal TREC Kit, the first approved kit for the detection of neonatal severe comprehensive immunodeficiency (SCID). According to the US CDC, approximately 40-100 neonates with severe integrated immunodeficiency (SCID) are diagnosed each year in the United States. SCID is caused by genetic defects involved in the development of T cells and other anti-infective immune cells. Newborns with SCID are not normal at birth, but the most dangerous is that they are life-threatening due to infection in the months following birth. Without early intervention and treatment, newborns usually die within one year of birth, and early intervention can greatly improve survival. The EnLite Neonatal TREC Kit is very simple to use and requires only a few drops of blood from the heel of the newborn. The kit detects the reduction or deletion of the T cell receptor resected loop DNA sequence (TREC DNA) in the neonatal genome. It is a feature of newborns with SCID. FDA officials said that after the launch of the EnLite Neonatal TREC Kit, it is hoped that the United States will be able to carry out early screening and intervention treatment of SCID to improve the survival rate of children. To date, 25 states have agreed to screen SCIDs and require only FDA-approved kits. The FDA's approval of the EnLite Neonatal TREC Kit includes a clinical trial of 6,400 blood samples in which 17 SCID patients have been detected by routine means, and the EnLite Neonatal TREC Kit accurately detected this 17 Samples. The EnLite Neonatal TREC Kit is manufactured by Wallac Oy, a subsidiary of PerkinElmer. Original FDA allows marketing of the first newborn screening test to help detect Severe Combined Immunodeficiency The US Food and Drug Administration today allowed marketing of the EnLite Neonatal TREC Kit, the first screening test permitted to be marketed by FDA for Severe Combined Immunodeficiency (SCID) in newborns. According to the Centers for Disease Control and Prevention, approximately 40 to 100 new cases of SCID are identified in newborns in the United States each year. SCID is a group of disorders caused by defects in genes involved in the development and function of T cells and Other infection-fighting immune cells.Babies with SCID appear normal at birth, but typically develop life-threatening infections within a few months. Without early intervention and treatment, death can occur within the baby's first year; early detection and treatment can markedly improve survival . Using a few drops of blood taken from the newborn's heel, which is dried on filter paper, the EnLite Neonatal TREC Kit can determine whether a certain type of DNA, known as T-cell receptor excision circles (TREC DNA), is low or missing From the newborn's blood. Newborns with SCID typically have zero or low amounts of TREC DNA compared to healthy infants. Additional testing is required to obtain a SCID diagnosis. "SCID is a fatal disease that can be treated with early intervention, including screening," said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in FDA's Center for Devices and Radiological Health. "For the First time, the FDA is allowing the marketing of a newborn screening test that will enable states to incorporate an FDA reviewed SCID test into their standard newborn screening panels and allow earlier identification for affected individuals,†added Gutierrez. The Secretary of the US Department of Health and Human Services and the Advisory Committee on Heritable Disorders in Newborns and Children recommend that every state screen newborn infants for SCID, among other genetic, endocrine and metabolic disorders. To date, 25 states plus the District of Columbia and the Navajo Nation have implemented screening programs for SCID. Some states have regulations requiring that their newborn screening program use an FDA-approved or FDA-cleared test. The FDA's review included a clinical study of approximately 6,400 blood spot specimens from routine screening of newborns, 17 of which had confirmed SCID diagnosis. The EnLite Neonatal TREC Kit correctly identified all 17 SCID cases. The EnLite Neonatal TREC Kit is manufactured by Wallac Oy, a subsidiary of PerkinElmer, at its facility in Turku, Finland. PerkinElmer is based in Waltham, Massachusetts. Source: CFDA Heat-Resistant Gloves,Heat Proof Gloves,Fireproof Gloves,Heat Protection Gloves Jiangsu Hespax Security Co., Ltd , https://www.hespax.com