The story has been updated to include comments from Meridian Bioscience.
NEW YORK (360Dx) – The US Food and Drug Administration and the Centers for Disease Control and Prevention today advised people who got tested for lead poisoning with technology from Magellan Diagnostics get retested due to inaccurate results.
The warning covers all four Magellan Diagnostics' lead testing systems — LeadCare; LeadCare II; LeadCare Plus; and LeadCare Ultra. The FDA warning is based on data indicating Magellan's tests, when performed on blood drawn from a vein, may provide results that are lower than the actual level of lead in the blood, the agencies said. They added that the issue may date as far back as 2014.
The FDA and CDC noted that all LeadCare Systems can be used with blood from a finger or heel stick, including the LeadCare II system, which is found in many physicians' offices and clinics. Today's warning does not cover testing carried out in such manners. Some laboratories offer alternative methods of lead testing, which also is not believed to be affected at this time.
"The FDA is deeply concerned by this situation and is warning laboratories and healthcare professionals that they should not use any Magellan Diagnostics' lead tests with blood drawn from a vein," said Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, in a statement. "The agency is aggressively investigating this complicated issue to determine the cause of the inaccurate results and working with the CDC and other public health partners to address the problem as quickly as possible."
The CDC recommends that parents of children younger than 6 years of age, and women who are currently pregnant or nursing, and who have been tested for lead exposure, consult a healthcare professional about getting retested. It also recommends healthcare professionals retest children younger than 6 if their test was done using blood drawn from a vein with any of Magellan's LeadCare System test, and they received a result of less than 10 micrograms per deciliter.
The CDC further recommends retesting for women who are currently pregnant or who are nursing and were tested with Magellan's lead testing technology while pregnant or nursing. Other adults concerned about their risk or the risk of an older child should consult with a healthcare professional about getting retested.
Magellan is an independent business unit of Meridian Bioscience.
In a letter to physicians and labs who provide Magellan's tests, the company said that it is working closely with the FDA to address its concerns.
It stressed that the majority of lead tests performed on the LeadCare System use capillary samples obtained by a finger or heel stick and "there have been no performance issues identified associated with capillary testing."
Separately, Meridian Bio said in a statement that blood sample testing on Magellan's systems comprise about 10 percent of Magellan's total revenues and about 1 percent of Meridian's total revenues. "Meridian and Magellan do not expect this occurrence to cause any material adverse effect to Meridian's financial results," the firm said, adding it will work "closely and fully" with the FDA and CDC.
In a note, Piper Jaffray analyst William Quirk wrote that while Magellan represents a small portion of Meridian Bio's revenues, it "is a critical growth driver for the company. We believe there will be reputational damage to Meridian/Magellan and it is possible Magellan revenue could fall by as much as 50 percent as physicians unplug systems."
Nicholas Jansen of Raymond James added, "[F]inancial quantification is a bit difficult to handicap at this time, but we would assume that growth in the platform could slow meaningfully with this news. With Magellan only one of a few assets actually growing at Meridian, this disclosure could create another setback for top-line recovery."
In afternoon trading on the Nasdaq, shares of Meridian Bio were down more than 8 percent to $13.50.