FDA Clears Test to Detect Most Severe Form of Lupus

Scientists in Seattle have been cleared by the Food and Drug Administration to market a new screening test for the most severe form of lupus, a sometimes fatal disease so deceptive in its development that it can be mistaken for everything from severe sunburn to clinical psychosis.

Systemic lupus erythematosis, or SLE, is the most virulent form of the disease that attacks tissues of the body’s vital organs, including brain, heart and kidneys. Early detection, crucial in protecting organs from lasting damage, has been elusive.

Experts on the disease say the test, developed by Dr. Mark Roth of the Fred Hutchinson Cancer Research Center’s Basic Sciences division, will close the gap in the 20% of SLE cases that escape detection and remain undiagnosed for months or years.

Duane Peters of the Lupus Foundation of America described the news as important and exciting.

Judith James, associate professor of medicine at the Oklahoma Medical Research Foundation, affiliated with the University of Oklahoma, agreed, saying that “there has never been a definitive, clear-cut answer in terms of a test” for the disease.

Estimates of lupus sufferers in the U.S. range from a low of 250,000 to as many as 1.4 million. But scientists said 10 times that number may have the disease and need testing.

Peters said the national Centers for Disease Control and Prevention has issued a request for proposals to more clearly establish the number of lupus sufferers in the nation.

The disease primarily affects women in their child-bearing years. African American women are two to three times more likely than whites to have the disease.

The case of Angela Calger, a 32-year-old Oklahoma City resident, is an example of the suffering SLE victims might have to endure without a correct diagnosis.

In 12 years, Calger had two miscarriages and many debilitating illnesses because of flare-ups of lupus before she was finally told last year that she had the ailment.

“It would have been nice if it could have been diagnosed a lot sooner,” Calger said.

Labeled “the great mimicker,” the disease can flare from simple exposure to the sun. That’s what happened to Calger in her most recent and most serious attack, which has been quieted but remains active, she said. Over the years, her disease was diagnosed by doctors as a false positive for a sexually transmitted disease to a severe case of anemia.

The Seattle-based Hutchinson center has cleared the FDA’s requirements for the screening test, which uses proteins to detect lupus antibodies in the blood.

If the antibodies are present, the sample turns deep purple or almost black. Not every lupus sufferer has the antibodies, said James, so the test would have to be used in concert with other tests.

Roth said the center is negotiating with firms interested in manufacturing and distributing the test.