CFDA Clearance for LeadCare II in China
BILLERICA, Mass., Aug. 9, 2016 /PRNewswire/ — Magellan Diagnostics, a business unit of Meridian Bioscience (NASDAQ: VIVO), 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.”
About Magellan Diagnostics, Inc.
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. 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. For more information, visit www.magellandx.com.
About Meridian Bioscience, Inc.
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. Utilizing a variety of methods, these products and diagnostic tests provide accuracy, simplicity and speed in the early diagnosis and treatment of common medical conditions, such as gastrointestinal, viral and respiratory infections and blood lead levels. Meridian’s diagnostic products are used outside of the human body and require little or no special equipment. The Company’s products are designed to enhance patient well-being while reducing the total outcome costs of health care. Meridian has strong market positions in the areas of gastrointestinal and upper respiratory infections; serology, parasitology and fungal disease diagnosis, and blood lead level testing. In addition, Meridian is a supplier of rare reagents, specialty biologicals and related technologies used by biopharmaceutical companies engaged in research for new drugs and vaccines. The Company markets its products and technologies to hospitals, reference laboratories, research centers, diagnostics manufacturers and biotech companies in more than 70 countries around the world. The Company’s shares are traded on the NASDAQ Global Select Market, symbol VIVO. Meridian’s website address is www.meridianbioscience.com.