By Ron Shinkman, Editor, Laboratory Industry Report
Magellan Diagnostics has received 510(k) regulatory approval from the U.S. Food and Drug Administration to market a new point-of-care test that would be used to test lead levels in blood.
The test, known as LeadCare Plus, is a point-of-care version of a test the Massachusetts-based Magellan has marketed in other guises for the past 20 years.
The LeadCare Plus system operates from a black box that is about the same size as an iPad mini. It analyzes blood samples placed on test strips and can run as many as 20 samples per hour. Turnaround time is three minutes per test. It operates in conjunction with disposables Magellan sells in a package that is able to conduct up to 96 assays in all.
About one in 38 children in the United States under the age of 5 are exposed to dangerous levels of lead, according to data from the U.S. Centers for Disease Control and Prevention. The condition can lead to loss of intellectual capacity, attention disorders and other health problems. But there are few early symptoms of the medical condition, which can usually only be detected near its onset with a blood test.
“We are pleased that the FDA has cleared the LeadCare Plus System,” said Magellan President Amy Winslow in a statement. “Our mission is to help expand access to blood lead testing by offering a solution for every setting. With our other products … LeadCare Plus completes this offering by providing a low capital cost system that gives even small labs the opportunity to bring this test in-house."