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FDA Clears for Market New Diagnostic Test for Lupus

  [ 30 votes ]   [ Discuss This Article ] • August 29, 2002

Test will help bridge detection gap for systemic lupus erythematosis, or SLE

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 person’s 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 that’s 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 Hutchinson’s 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.

This discovery spawned the development of a color-coded test to detect the presence of telltale SR proteins in the serum, the clear-fluid portion of the blood. The test, called the “Anti-SR protein antibody assay,” involves adding sera to tiny wells in a plastic plate that has been coated with human SR proteins. A colored molecular tag detects antibodies in the sera that stick to the SR proteins. Sera from people with lupus turns purple, while sera from non-affected individuals remains clear. This test can identify 50 percent to 70 percent of lupus patients who react positively to SR proteins.

“It is often difficult to predict who will flare from lupus or when. This test makes it easier to make such predictions,” said Lahita, professor of medicine at NYMC and chief of rheumatology at St. Vincent’s Hospital and Medical Center, who has authored several textbooks and publications about immune diseases and lupus and is the editor of Systemic Lupus Erythematosus.

The initial idea behind the test arose from a scientific experiment more than a decade ago, when Roth and colleagues injected mice with extracts of frog nuclei. Antibodies produced by these mice led to the discovery of the SR proteins used in this new screening test.

Fred Hutchinson has filed for patent protection on this assay system and is actively seeking a commercial partner that can make the test available to the public in the near future.

“FDA clearance should facilitate the transfer of this technology to companies that can make the test widely available to the public,” said Linda Clarke, director of Fred Hutchinson’s Technology Transfer Office.

Funding for this research came from the National Institutes of Health and Fred Hutchinson’s New Technology Development Fund, which helps translate basic research to public benefit by providing funding to demonstrate proof-of-principle.

Those interested in more information about licensing opportunities for this or other Fred Hutchinson technology can contact its Technology Transfer Office at (206) 667-4304.

The Fred Hutchinson Cancer Research Center, home of two Nobel Prize laureates, is an independent, nonprofit research institution dedicated to the development and advancement of biomedical technology to eliminate cancer and other potentially fatal diseases. Fred Hutchinson receives more funding from the National Institutes of Health than any other independent U.S. research center. Recognized internationally for its pioneering work in bone-marrow transplantation, the center’s four scientific divisions collaborate to form a unique environment for conducting basic and applied science. Fred Hutchinson is the only National Cancer Institute-designated comprehensive cancer center in the Pacific Northwest and is one of 41 nationwide. For more information, visit the center’s Web site at

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