ImmunArray rolls out lupus blood test
Following a limited three-month trial period in which more than one hundred and fifty patients with lupus-like symptoms were tested for the difficult-to-diagnose disease, a new blood test for lupus is being rolled out nationally.
The test involves uses a technology that allows rheumatologists to rule out the presence of systemic lupus erythematous with meaningful levels of accuracy. The initial clinical study was performed on blood samples from more than 500 patients in collaboration with international leaders in the lupus field. The data have been presented at four U.S. and international scientific conferences in 2015, and additional data will be reported in November at the American College of Rheumatology scientific meeting.
The SLE-key testing platform was developed and patented by ImmunArray, a molecular diagnostic company co-headquartered in Richmond, Va., and Rehovot, Israel. Initial clinical testing using SLE-key revealed it can rule out a diagnosis of lupus with a sensitivity of 94 percent and a specificity of 75 percent.
The SLE-key test looks for the presence of nearly 200 biomarkers in a patient’s blood. The test assesses a patient’s immune system more broadly, providing important information related to a patient’s underlying health. As data generated from this broad view of the immune system is studied, it may be possible to enhance a physicians’ ability to monitor a patient’s immune system and improve ongoing care for lupus patients. The SLE-key test employs ImmunArray’s iChip technology. Analysis of the test results takes place at Veracis, ImmunArray’s CLIA laboratory in Richmond.