ImmunArray launches SLE-key Rule-Out test for lupus patients

Oct 12 2015

SLE-key^TM Rule-Out test becoming more widely available through leading rheumatologists

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. This will provide a wider group of rheumatologists with a simple, accurate means for ruling out whether a patient is suffering from the chronic, autoimmune disease that affects 1.5 million Americans, mostly women between the ages of 18 and 60.

The test involves the use of a breakthrough technology that allows rheumatologists to rule out the presence of SLE (Systemic Lupus Erythematous or “lupus”) 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 has been presented at four US and International scientific conferences to date in 2015 and additional data will be reported in November at the American College of Rheumatology scientific meeting.

Key users are already confirming its application and efficacy. “One of my patients with a positive ANA test who had been prescribed with an SLE drug was discontinued from the drug when clinical suspicions were reinforced by results from an SLE-key^TM test,” said Guillermo Valenzuela, M.D., of Integral Rheumatology and Immunology Specialists in Plantation, Fla. “I am convinced of the value of the test, and it has been extended to several patients already.”

According to Donald Massenburg, MD PhD, Rheumatology and Immunotherapy Center (RITC) Franklin, Wis.:

I can now tell the patient, you don’t have lupus. Now let’s go find out what you do have.

The SLE-key^TM testing platform was developed and patented by ImmunArray, a molecular diagnostic company co-headquartered in Richmond, Virginia and Rehovot, Israel. Initial clinical testing using SLE-key^TM revealed levels of diagnostic accuracy that exceed any other test for lupus to date. It is able to rule out a diagnosis of SLE with a sensitivity of 94 percent and a specificity of 75 percent.

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