BILLERICA, Mass., Dec. 1, 2016 /PRNewswire/ -- Magellan Diagnostics, the developer of a diagnostic system that tests for lead exposure in minutes, is marking ten years of delivering this point of care solution to physicians. Based on technology originally developed with grant funding from the Centers for Disease Control and Prevention (CDC), Magellan's LeadCare ® II system was approved by the FDA in 2006 as the first and only CLIA-waived point of care lead testing system. Since then, Magellan has shipped more than 10,000 units and over 13 million tests - which, on an annual basis means up to half of US childhood lead screening is performed using LeadCare II.
"There is no quick, simple way to eradicate lead exposure, but as a nation we've made progress on reducing the threat," said Amy Winslow, president and CEO of Magellan Diagnostics. "The challenge is that, while the most significant exposure sources are dwindling, there are still many ways that lead can sneak into our environment, and scientists have demonstrated that even low levels of exposure cause harm - especially to the developing brains of infants and toddlers." While exposure to even small amounts of lead can have life-long effects, the vast majority of cases are without symptoms. As a silent poison, lead is typically only detected through routine blood lead testing. This testing is the only way to be sure that vulnerable populations - especially young children and pregnant women - are not exposed. The innovation of LeadCare II, allowing the test to be accomplished in the doctor's office with only two drops of blood from a simple fingerstick, has dramatically improved testing rates.