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Instrumentation Laboratory Receives FDA Clearance for New Automated Total Bilirubin Assay on GEM Premier 4000 Critical Care Analyzer
Date:7/27/2010

ANAHEIM, Calif., July 27 /PRNewswire/ -- Instrumentation Laboratory (IL) today announced that it has received clearance from the US Food and Drug Administration (FDA) to market the first-ever, rapid point-of-care, lab-quality blood test for measuring total bilirubin (tBili) in newborns.  

Bilirubin, a toxin, can, in high amounts, lead to irreversible brain injury in neonates.  The new tBili assay is performed on IL's GEM Premier 4000 critical care analyzer.  It allows clinicians to receive lab-quality test results in 90 seconds from whole blood in the Neonatal Intensive Care Unit (NICU), rather than waiting up to an hour for results from the lab, using traditional chemistry methods.    

During the first few days of life, the body breaks down fetal red blood cells, producing bilirubin.  More bilirubin is produced than the liver can remove, and it remains circulating in the blood.  This results in jaundice, the most common condition requiring medical attention in newborns, present in approximately 70%.  However, in 8-10% of newborns, jaundice progresses to severe hyperbilirubinemia.  Left untreated, hyperbilirubinemia can quickly evolve into kernicterus, a devastating, irreversible neonatal brain injury.  

"Over the past decade, kernicterus has reemerged, due to a variety of factors," said Anthony Napolitano, M.D., a Neonatologist, Medical Director, Neonatal/Pediatric Transport Program at All Children's Hospital, St. Petersburg, FL and Medical Director, Sarasota Memorial Hospital, Sarasota, FL.  "The ability to assess bilirubin in the NICU with accuracy and precision is a tremendous advantage and has the potential to prevent this absolutely devas
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