ImmunArray to launch SLE-key Rule Out test for lupus in select U.S. markets

Jun 17 2015

Company says SLE-keyTM “rule-out” test will launch in selected U.S. markets on July 1

At the premier European forum on rheumatologic disorders, ImmunArray, maker of a breakthrough technology that provides unprecedented levels of accuracy in ruling out the presence of lupus through a simple blood test, announced today that it is launching its new SLE-key™ Rule Out test in selected U.S. markets on July 1, 2015.

The announcement coincides with the company’s presentation at EULAR (European League Against Rheumatism) Conference detailing the clinical development of ImmunArray’s pioneering SLE-Key serologic test, based on the company’s patented iCHIPTM technology.

SLE-key™ is based on results from more than 500 patients, whose blood was tested against 200 antigens each. The results were able to rule out a diagnosis of SLE (Systemic Lupus Erythematous) with a sensitivity of 94 percent and a specificity of 75 percent, levels of accuracy that far exceed any other test for lupus to date.

The testing platform was developed and patented by ImmunArray, a molecular diagnostic company co-headquartered in Richmond, Virginia and Rehovot, Israel. The SLE-key™ platform gives physicians the most precise and easy-to-use means for ruling out the presence of lupus, a chronic, autoimmune disease that is among the most difficult conditions to diagnose.

“Medical science – and the field of rheumatology, in particular – has long been frustrated by our inability to diagnose lupus with any degree of sophistication or certainty,” said D. Scott Batty, Jr., MD, CEO of ImmunArray. “The development of the SLE-key™ is a groundbreaking achievement that now gives rheumatologists a highly accurate diagnostic tool that can rule out the presence of lupus with unparalleled levels of confidence. We look forward to rolling out the SLE-key™ in the coming weeks through a partnership with some of the country’s most respected rheumatologists and then building our testing capacity toward a broader availability later this year.”

The SLE-key™ test employs ImmunArray’s patented iCHIP™ technology, a breakthrough in the ability to detect and monitor human health and disease through the analysis of precise biomarkers that may or may not be present in a patient’s blood. Analysis of the test results takes place at ImmunArray’s VERACIS™ laboratory in Richmond, Va.