FDA clears IL's new point-of-care total bilirubin assay

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 devastating outcome and reduce hospital readmissions."

The American Academy of Pediatrics recommends that a risk-assessment for bilirubin be performed on every newborn to reduce the incidence of adverse events.

"Now, with the addition of the tBili assay to the GEM Premier 4000 analyzer, screening can be performed immediately, with the highest quality results assured," said Ramon Benet, VP of US Sales and Worldwide Service and Marketing at IL.  "No other analyzer can provide lab-quality tBili results in the NICU."

tBili assays performed on the GEM Premier 4000 are not affected by moderate turbidity or hemolysis, ensuring accuracy.  Additionally, from a single whole blood sample, a full range of analytes can be measured, including Blood Gas, Electrolytes, Glucose, Lactate and full CO-Oximetry, for an efficient and comprehensive assessment of patient status.

"At IL, we are intensely focused on continuously improving our products to enhance patient care," Benet added.  "Helping clinicians to eradicate kernicterus and detect rising tBili early, while still treatable, is a very gratifying outcome of our efforts."

IL announced the FDA clearance of the tBili assay at the Annual Meeting of the American Association for Clinical Chemistry in Anaheim, California.  At the meeting, IL also introduced GEMweb Plus Custom Connectivity, software for automated information management.  GEMweb Plus is the only software to provide system-wide, bi-directional capabilities from any networked PC of GEM Premier 4000 analyzer.  GEMweb Plus provides complete control of all networked analyzers, regardless of location, to enhance quality assurance and regulatory compliance.