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Magellan Diagnostics gets Chinese approval for LeadCare II blood lead testing system

MDBR Staff Writer Published 11 August 2016

The China Food and Drug Administration (CFDA) has approved Magellan Diagnostics' LeadCare II blood lead testing system.

By using two drops of blood, the small and portable system produces a quantitative blood lead level in around three minutes.

Magellan said the LeadCare II is used in thousands of pediatric and primary care settings in the US to enable doctors diagnose lead exposure quickly and easily. 

Lead exposure, which is a significant global environmental health concern, is more in areas where lead-related industries, including battery manufacture/recycling, e-waste disposal, mining and smelting, are situated.

Magellan Diagnostics CEO Amy Winslow said: "Lead is a well-known health threat, especially for young children for whom it can cause developmental delays, behavioral issues and even seizures.

“We are pleased to have obtained approval to market LeadCare II in China, where we hope it can help broaden the availability of lead testing, as it has in the US, and spare children the life-long challenges of lead exposure.”

Meridian Bioscience CEO Jack Kraeutler said: "No child should have to suffer the lasting effects of lead exposure, which can be managed if high levels are diagnosed and corrective action is taken.”

Specifically focusing on lead testing, Magellan Diagnostics provides point-of-care systems, clinical laboratory instruments, and analytical laboratory services to its customers.

Meridian develops and markets a range of diagnostic test kits, purified reagents and related products. It also provides biopharmaceutical enabling technologies.