Diagnostics & Imaging Week

CHICAGO Magellan Biosciences (Chelmsford, Massachusetts) was ready to show off its LeadCare II device for blood lead testing, even while the device is awaiting a CLIA waiver at the American Association for Clinical Chemistry's (AACC; Washington) annual meeting and Clinical Lab Expo at McCormick Place, where about 635 companies are exhibiting products or services.

LeadCare II is the second device by ESA Biosciences (also Chelmsford), a subsidiary of Magellan. However, that device was considered "moderately complex" by the FDA, while LeadCare II will provide results at the point of care (POC).

"We're as certain as one can be that we'll get the CLIA waiver soon," Robert Rosenthal, PhD, CEO of Magellan, told Diagnostics & Imaging Week on the exhibition floor.

According to Rob Morse, support and marketing manager for Blood Lead Products at ESA, lead testing originated in the U.S. as a result of lead in gas and paint. Lead in gas was ultimately eliminated, leaving only lead paint concerns in housing.

"At that point, the CDC [Centers for Disease Control and Prevention; Atlanta] started to realize what we really need to do is to get out and do the testing where the problem really exists, where it's at its most acute," Morse told D&IW. "And the problem that they had was that those were the people that were hardest to reach."

Lead paint poisoning is primarily a problem in poor, urban areas and in older housing. And even though people in poor areas received vouchers through specific social services to encourage them to have their children get tested for lead poisoning, many did not act on it.

"In the U.S., there are about 800 labs that are certified to do blood lead testing," Morse said. "Half of those use the predecessor to [LeadCare II], so we're very well known in blood lead testing. But the issue is that those 800 labs are accomplishing less than 30% of the lead testing that is supposedly mandated, and so that's why the CDC's feeling is that while that testing is well-established, it needs to be supported by this [point-of-care] testing.

The CDC "called on ESA" to help them develop a device at the point of care, and the agency funded the development of LeadCare II, Morse said.

According to ESA, lead poisoning can "affect nearly every system in the body" and is a "silent epidemic" because there often are no obvious symptoms to indicate that a person has suffered lead exposure. And it can be particularly serious for children, where it may cause learning disabilities, behavioral problems or, in one instance in Minnesota, even death.

The company said that a 2002 study estimated the total economic impact of lead poisoning in the U.S. at $43 billion annually. It is further estimated that about 310,000 children in the U.S. ages 1 to 5 have blood-lead levels greater than 10 micrograms of lead per deciliter, the threshold set by the CDC indicating when patients enter a danger zone, ESA said. And many children experience problems at even lower levels.

Because LeadCare I was considered a moderately complex device, it could only be placed in labs of a certain size with staff trained specifically for its operation. Unfortunately, many children in poor, urban areas many of whom are served by Medicaid did not have access to this level of care. That was a driving force for the POC device to take blood lead testing to where it was most needed.

If, in fact, the device secures a CLIA waiver, it will be approved for operation by virtually anyone and can be placed in any healthcare facility that can draw blood.

The small, compact device requires two drops of blood that goes on the test strip at a point marked with an X. Then the operator simply pushes a button and the data is generated on a screen right before the patient.

Rosenthal noted that because the lead blood testing is reimbursable, the device would be marketed to physicians as a "revenue-generator." Since lead blood testing is required in all children of a certain age, physicians will be able to conduct the tests on the LeadCare II device, which costs "a few thousand dollars," and still get reimbursed at a rate of anywhere from $15 to $20 per test, depending on the state where they are located.

In those areas other than Medicaid facilities, "For doctors, the economics are pretty good."

The device also is designed as a platform, Rosenthal said, that the company expects to further develop for a variety of different POC tests, such as for levels of mercury.

The importance to the patient and family of POC testing is very real, according to the company. The experience of seeing a child being tested and getting results in about three minutes is very different than getting a phone call or report days later.

"The parents are involved and they're saying, 'Hey, you know, the paint is chipping off my window sill and there's dust on their toys,' and they're [then] trying to reduce the possibility of lead exposure to their kids," Morse said.