Magellan Diagnostics, a business unit of Meridian Bioscience, has received clearance from the China Food and Drug Administration (CFDA) for its LeadCare II Blood Lead Testing System. The system is small, portable, and produces a quantitative blood lead level in only three minutes, using just two drops of blood. This system is used in thousands of pediatric and primary care settings in the United States to help doctors diagnose lead exposure quickly and easily.
Lead exposure is a significant global environmental health concern, especially where lead-related industries, such as battery manufacture/recycling, e-waste disposal, mining and smelting, are common. In recent years, reports of lead exposure related to these industries in China have made it clear that a simple, accurate test could help clinicians better respond to parents' concerns about exposure in their children.
"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," said Amy Winslow, CEO of Magellan Diagnostics. "The rate of lead poisoning of Chinese children varies considerably, but may range from 9% to as much as 25% - far more than in the US, where the rate is 0.5%. With such a large population, it is clear that there are millions of children who should be tested."
"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," said Jack Kraeutler, CEO of Meridian Bioscience. "An important consideration in our acquisition of Magellan Diagnostics was the opportunity to bring this rapid testing to China, where we have an expanding presence. Obtaining CFDA approval for LeadCare II will bolster the portfolio of unique products that we offer, adding to our growth in that region."
Magellan Diagnostics is a medical device company that provides point-of-care systems, clinical laboratory instruments, and analytical laboratory services focused on lead testing. A business unit of Meridian Bioscience, Inc., Magellan is headquartered outside Boston in Billerica, Massachusetts, and is dedicated to offering high-quality, reliable products that help identify children and adults at risk of harm due to lead exposure.
Meridian is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic test kits, purified reagents and related products and offers biopharmaceutical enabling technologies.