Magellan gets U.S. approval for lead poisoning test
By John Larrabee, http://www.bizjournals.com
More children will likely be tested for lead poisoning, thanks to a new clinical testing system recently developed by Magellan Diagnostics Inc., a life science company based in Billerica, Mass.
The company announced Monday they have received FDA approval to market the new device, dubbed LeadCare Ultra. According to company president Amy Winslow, it will make testing easier and less expensive, and could be in hospital laboratories as early as next month, she added.
“We believe there are a lot of children who should be lead tested, but aren’t,” Winslow said. “This will help people get the testing they need.”
According to the Centers for Disease Control, over half a million children in the U.S. have elevated blood lead levels, which can impair cognition, reduce IQ, and cause attention-deficit disorder. A blood test is the only way to identify an exposed child.
Magellan Diagnostics first developed the testing technology in the ’90s, for use in a portable device they also manufacture. The new LeadCare Ultra Systems makes laboratory testing more efficient. Until now, technicians tested samples one at a time; with the new device they can test six at a time, and up to 90 in an hour.
“It’s based on an electro-chemical technique we’ve used with our portable system since the 2005,” Winslow said. “It’s called anodic stripping voltammetry. A testing strip with a gold cathodic is inserted into an analyzer. By using an electric impulse, lead is collected on the gold. By rapidly switching the current from negative to positive, you can collect and measure the lead.” Read More