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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.
"Our pediatric office recently acquired the LeadCare II and we have begun in-office lead testing," said Rebecca Couper, CPNP. "I must say that being able to provide our patients and families with a quick and easy in office testing for lead has been so helpful. Not only do we have a reliable result within a few minutes, but we also save the family from having to bring their child to the lab (a potentially scary place for our 1 and 2 year old kids). It has been an excellent addition to our practice."
With national attention on the issue of lead in drinking water, sparked by the tragedy in Flint, Michigan, public health officials and clinicians have worked to raise awareness of the threats of lead exposure. In particular, the concern about contaminated drinking water brings to light the risks to pregnant women. While the historical focus has been on risks to young children, there is now a body of evidence showing that lead readily crosses the placenta and harms developing nervous systems, even levels once considered "safe".
At-risk: pregnant women and their developing babies
It is estimated that 1% of pregnant women in the US are at risk for lead exposure, accordingly, both the CDC and the American College of Obstetricians and Gynecologists (ACOG) have recommended pregnant women with as little as one risk factor be tested. A test early in pregnancy can help identify and mitigate prenatal lead exposure, which causes lower birth weights, delayed or impaired intellectual development, as well as learning disabilities and behavior problems later in life.
"Raising awareness across all at-risk populations remains a key initiative for us," said Catherine Lufkin, marketing director at Magellan Diagnostics. "Awareness of the effects of lead exposure in young children is driving progress in the fight against lead poisoning. However, there is less awareness of the effects of lead exposure on pregnant women and their babies. We are committed to changing that."
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. Headquartered outside Boston in Billerica, Massachusetts, Magellan is dedicated to educating families, clinicians, policy makers, payers and communities about the permanent physical and mental health damage caused by lead exposure; and to offering high-quality, reliable products that help to quickly identify children and adults that are being exposed. For more information visit www.magellandx.com.
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