FDA clears for market new diagnostic test for lupus

his 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. Vincents 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 Hutchinsons Technology Transfer Office.


Contact: Kristen Woodward
Fred Hutchinson Cancer Research Center

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