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ImmunArray's New Lupus Rule-Out Test Broadening Availability

Monday, December 07, 2015  
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After presenting at the annual meeting of the American College of Rheumatology in San Francisco last month – its sixth presentation at international medical conferences in as many months – the developer of a new rule-out test for lupus is broadening the test’s availability throughout the United States.

ImmunArray, developer of SLE-key Rule-Out Test – a simple, cost-efficient blood test that can rule out the presence of Systemic Lupus Erythematosus (SLE or lupus) with unprecedented levels of accuracy – is now available through leading rheumatologists in all regions of the country.

Launched this past summer in limited markets, test results to date on blood samples from more than 160 patients’ blood have determined that as many as two in three patients (65%) who were thought to have lupus on the basis of a positive ANA test, in fact, did not. In an extensive clinical trial of 500 patients, SLE-key was able to rule out a diagnosis of SLE with a sensitivity of 94 percent and a specificity of 75 percent.

David Pisetsky, M.D., Ph.D., professor of Medicine and Immunology at the Duke University School of Medicine, sees the value of the SLE-key test in providing valuable information as part of the evaluation of a patient suspected of having SLE.

“Currently, our strategy for considering the possibility of lupus often necessitates many different laboratory tests and even imaging studies,” he said. “Having a test to help rule out a complex diagnosis like SLE right at the outset allows for a more direct approach to patient management, saving both time and money.”

ImmunArray has developed SLE-key® with the guidance of some of the nation’s leading academic and clinical rheumatologists and the test’s early adopters are some of the top rheumatologists specializing in lupus in the country.

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