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Magellan Diagnostics Receives FDA Clearance for LeadCare Ultra Bench-top Clinical Lead Analyzer
Date:8/26/2013

BILLERICA, Mass., Aug. 26, 2013 /PRNewswire/ -- Magellan Diagnostics, Inc., the leader in clinical lead testing systems for both point-of-care and laboratory analysis, has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market the LeadCare Ultra Blood Lead Testing System in the US for the quantification of lead levels in blood. 

LeadCare Ultra is the first "plug-and-play" solution for laboratory lead analysis.  It brings a significant improvement in the speed and cost of lead testing while providing labs the first bench-top lead testing system with an easy-to-use and flexible design.  

"Our lab was impressed by how easy LeadCare Ultra was to set up and run," said Lindsay Gauthier, Chemistry Manager at Cambridge Hospital in Cambridge, Massachusetts, who participated in the system's clinical trial.  "Compared to other systems, which can require significant maintenance and monitoring, Ultra really simplified our workflow."

According to the Centers for Disease Control and Prevention (CDC), there are over half a million US children affected with elevated blood lead levels, which can impair cognition, reduce IQ, and cause attention-deficit disorders.  Because the symptoms of lead exposure are non-specific and often sub-clinical, a blood test is the only way to identify an exposed child.

Amy Winslow, president of Magellan Diagnostics, said, "We are pleased that the FDA has cleared the LeadCare Ultra System. Since there are still many children and adults at risk of lead exposure who don't get tested, we feel it is important to offer solutions that can help expand access to lead testing.  LeadCare Ultra does this by offering a simple, cost effective solution for laboratories of all sizes." 

The LeadCare Ultra System is based on technology developed by Magellan
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SOURCE Magellan Diagnostics
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