New Test for Lupus May Help Stem Rising Death Toll in Young Women
by Sophia Cariati

(Washington DC, 10/3/02):  The U.S. Food and Drug Administration recently cleared for market a new diagnostic test for lupus that promises to boost the detection rate and facilitate earlier treatment of this hard-to-identify disease which has taken an ever-increasing death toll on young women.  Lupus, also known as systemic lupus erythematosis or SLE, is a poorly understood condition in which the body's misdirected immune system attacks its own healthy tissue causing pain, fatigue and damage to vital organs. Approximately 90% of the estimated 1.4 million Americans with lupus are young women between 15 and 45 years old.  A recent report of the Centers for Disease Control and Prevention (CDC) revealed a 70% increase in the proportion of African-American women dying from lupus over the last 20 years. The same study found that death rates were more than five times higher for women with lupus than among men with the disease.

"Any test that can improve the rate of diagnosis is a significant breakthrough for patients with lupus," says Duane Peters, Vice President of Advocacy and Communications at the Lupus Foundation of America (LFA) in Rockville, Maryland. "Timely detection will allow doctors to treat lupus early before the disease progresses undetected, causing organ damage and even death."

Since the symptoms of lupus are somewhat unpredictable and often vary from patient to patient, receiving a timely and accurate diagnosis can be a frustrating, long, and drawn-out process. In fact, half of patients with lupus consult three or more doctors over the course of four or more years before being correctly diagnosed, according to a survey by the LFA.

The newly approved screening method has the potential to simplify diagnoses for patients and physicians alike. The novel test may help promote earlier detection by picking up some of the 20% of lupus cases that regularly fall through the cracks with older diagnostic tests, according to Mark Roth, Ph.D, who developed the test with colleagues at the Fred Hutchinson Cancer Research Center in Seattle.

"This test will improve the ability of doctors to make correct decisions when diagnosing SLE, and we also have evidence that this test is of value in determining where in the body the disease will present itself," said Roth, also an affiliate associate professor of biochemistry at the University of Washington School of Medicine, in a prepared statement.

Yet experts warn that this is far from a definitive test. "This is not a perfect screen," said George Tsokos, MD, Director of Rheumatology at the Uniformed Services University in Bethesda, MD. "It will complement the tests already available, but not all patients with lupus will test positive with this method." Nevertheless, this new method helps fill a definitive need for better lupus diagnostics, according to Dr. Tsokos.

The power of the new test hinges on its ability to detect antibodies to so-called SR proteins. Antibodies are compounds made to target a particular protein when the body launches an immune attack. Two years ago, Roth and colleagues discovered that the majority of patients with lupus produce antibodies to SR proteins while patients with other diseases are much less likely to manufacture SR antibodies. The study results were published in the August 2000 issue of the journal Arthritis and Rheumatism.

Based on these findings, Roth and colleagues developed the new lupus screen. The color-coded test involves adding a patient's serum, the clear-fluid portion of the blood, to a laboratory dish containing SR proteins. If the patient has made antibodies to SR proteins, the sera will react with the proteins and turn the liquid purple. This test can identify 50 to 70% of lupus patients who react positively to SR proteins, according to the FDA.

It may be some time before patients benefit from this research. Currently the Fred Hutchinson Cancer Research Center is looking for a commercial partner that can manufacture the test, which officials expect to become available to the public in the "near future."

The Society for Women's Health Research is the nation's only not-for-profit organization whose sole mission is to improve the health of women through research. Founded in 1990, the Society brought to national attention the need for the appropriate inclusion of women in major medical research studies and the resulting need for more information about conditions affecting women. The Society advocates increased funding for research on women's health, encourages the study of sex differences that may affect the prevention, diagnosis and treatment of disease, and promotes the inclusion of women in medical research studies. Dr. Donnica Moore has been a member of the Society since 1990 and is a past member of its Board of Directors.

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Created: 10/5/2002  -  by Sophia Cariati