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FDA clears for market new diagnostic test for lupus

SEATTLE The U.S. Food and Drug Administration has cleared for market a new screening test for lupus developed by researchers at the Fred Hutchinson Cancer Research Center. The test is considered the first significant diagnostic breakthrough for systemic lupus erythematosis, or SLE, in more than four decades.

The test is expected to pick up the 20 percent of SLE cases that previously fell through the cracks because they could not be detected by the most widely used, standard screening test.

Lupus is a chronic disorder in which a persons immune system attacks the body. SLE is the most severe and potentially fatal form of the disease, which causes inflammation of connective tissue throughout the body, from the joints to the kidneys. Because symptoms range from skin rash and mild fatigue to organ failure, diagnosis can be difficult.

While the majority of lupus patients produce antibodies to their own tissue that can be detected with a blood test thats been available since the early 1960s, about one-fifth of patients those who do not make such antibodies often go undiagnosed.

The new test, developed by Mark Roth, Ph.D., a member of Fred Hutchinsons Basic Sciences Division, promises to bridge that diagnostic gap.

This test will improve the ability for 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.

Two years ago, in the August 2000 issue of Arthritis and Rheumatism, Roth and colleagues at Fred Hutchinson and the University of Washington, in collaboration with New York Medical College rheumatologist Robert G. Lahita, M.D., Ph.D., first reported the discovery that molecules called SR proteins are particularly useful biomarkers for lupus because the majority of patients produce antibodies to them.

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Contact: Kristen Woodward
kwoodwar@fhcrc.org
206-667-5095
Fred Hutchinson Cancer Research Center
28-Aug-2002


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