REHOVOT, Israel & RICHMOND, Va.--(BUSINESS WIRE)--On the heels of its presentation 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.
The company has made six poster and podium presentations about the pioneering test at international conferences around the world over the past six months, including European League Against Rheumatism Congress (June in Rome), American Association for Clinical Chemistry annual meeting (July in Atlanta), LUPUS 2015 International Congress (September in Vienna), and the American College of Rheumatology annual meeting (San Francisco in November).
The SLE-key Rule-Out Test® was developed using the iCHIP®, a pioneering in-vitro diagnostic platform with multiple novel applications that have far-reaching implications – from tests that can rule out a diagnosis for lupus to tests that confirm or rule out brain injury following trauma or sports-related concussions.
Headway on TBI diagnosis
The recipient of a GE-NFL grant to explore the use of the iCHIP in the diagnosis of traumatic brain injury (TBI), ImmunArray reports that it has enrolled more than 400 patients in a prospective clinical study at a leading academic medical center and health care system. The study has attracted the interest of several companies with platforms that are interested in diagnosing and monitoring TBI.
Co-located in Rehovot, Israel and Richmond, Va., ImmunArray is a privately funded molecular diagnostics company dedicated to the development of novel blood-based tests that support the diagnosis and management of complex acute and chronic immune and neurodegenerative diseases. The company designs and analyzes sets of biomarkers known to be linked to a particular condition and develops tests on platforms that are most appropriate to facilitate the test adoption. The company, which introduced its first commercial tests in 2015, is currently conducting additional research in collaboration with leading clinicians and medical centers in the U.S. and Israel. It also has entered a research collaboration with a Fortune 15 company to study using biomarkers to identify traumatic brain injury. For more information about SLE-Key and ImmunArray, visit www.immunarray.com