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Magellan Diagnostics Receives FDA Clearance for LeadCare Plus Clinical Lead Analyzer

7/16/2015

BILLERICA, MA – July 16, 2015 – Magellan Diagnostics, Inc., the leader in blood lead testing systems for both point-of-care and laboratory analysis, has received US Food and Drug Administration (FDA) 510(k) clearance to market the LeadCare Plus Blood Lead Testing System in the US for the quantification of lead levels in blood. 

LeadCare Plus offers the simplest way to perform laboratory lead analysis with the most compact footprint, and makes blood lead testing accessible and practical for labs of any size.  With dimensions smaller than any laptop, single use consumables, and electronic calibration, the system is easy to implement in even the most space and resource constrained labs and clinics.  

Blood lead testing is a critical preventative service for children: the symptoms of lead exposure are non-specific and sub-clinical, therefore a routine blood test is often the only way to identify exposure in a child.  Without early detection, elevated blood lead levels can impair cognition, reduce IQ, and cause attention-deficit disorders. According to the Centers for Disease Control and Prevention (CDC), there are over half a million US children still affected with elevated blood lead levels.

Amy Winslow, president of Magellan Diagnostics, said, “We are pleased that the FDA has cleared the LeadCare Plus System. Our mission is to help expand access to blood lead testing by offering a solution for every setting.  With our other products, CLIA-waived LeadCare II for point-of-care testing and LeadCare Ultra for high throughput lab analysis, LeadCare Plus completes this offering by providing a low capital cost system that gives even small labs the opportunity to bring this test in-house.”

The LeadCare Plus System is based on technology developed by Magellan Diagnostics that has been in clinical use for nearly two decades and that is in use at over 6,000 locations, helping clinicians rapidly test and identify individuals who suffer from lead exposure.  All three products will be on display during the AACC Clinical Lab Expo in Atlanta, July 26-30, 2015 (Booth #3254).

About Magellan Diagnostics

Magellan Diagnostics is a medical device company that provides point-of-care systems, clinical laboratory instruments, and analytical laboratory services focused on lead testing. Headquartered outside Boston in Billerica, Massachusetts, Magellan is dedicated to offering high-quality, reliable products that help identify children and adults at risk of harm due to lead exposure.  We are committed to educating clinicians, policy makers, payers, families and communities about the permanent health damage caused by lead and how to detect and address lead exposure

Contact:  Matt Burke, mburke@magellandx.com, +1 603.315.0618

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