Rare Disease And Newborn Screening: FDA And Health Canada Allows Marketing Of 1st SCID Test
PerkinElmer, announces December 17th the 1st commercially available Newborn Screening (NBS) test in the U.S. and Canada for the rare disease, Severe Combined Immunodeficiency (SCID). The company receives market authorization from both the FDA and Health Canada for the VICTOR™ EnLite™ and EnLite™ Neonatal TREC Kit. With this approval, PerkinElmer’s SCID screening is now available in more than 30 countries globally.
SCID is a group of inherited disorders causing abnormalities of the immune system, resulting in reduced or malfunctioning specialized white blood cells (T- and B-Lymphocytes). These white blood cells are made in the thymus gland and bone marrow to fight infection. As a result of the immune system not functioning correctly, it is difficult or almost impossible for it to fight viruses, bacteria, and fungi that cause infections. There are 14 forms of SCID, with the most common type caused by a problem in a gene found on the X chromosome that affects only males. SCID affects approximately 1/58,000 newborns a year. SCID is also known as the “Bubble Boy” disease.
“The Secretary of the U.S. 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.” (Pharma Tutor Pharmacy Infopedia)
Please Note: “Newborn-Baby-Feet” by Evan-Amos (Own work) [Public domain] | Wikimedia Commons.