Blood Test to ‘Rule Out’ Lupus Now Widely Available in US

Ines Martins, PhD avatar

by Ines Martins, PhD |

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ImmunArray, a molecular diagnostics company developing blood-based tests to support the diagnosis and management of acute and chronic immune and neurodegenerative diseases, has announced that it is making its “rule-out” test for systemic lupus erythematosus (SLE) available throughout the United States.

The company’s SLE-key Rule-Out Test®  is a cost-effective blood test designed to confirm or rule out an SLE diagnosis with notable accuracy. ImmunArray announced the expansion after a recent presentation at the American College of Rheumatology’s (ACR) annual meeting, held in San Francisco.

SLE-key measures a patient’s SLE-specific antibody fingerprint and immune system activity, and works by determining the pattern of circulating antibodies to an array of antigens which are printed on ImmunArray’s proprietary iCHIP. This pattern is compared to SLE-affected and healthy control patterns. Analytic algorithms are then used to determine the likelihood of the patient being affected with SLE, along with a probability score. The test evaluates the immune system as a whole to support a rule-out decision, and results are delivered to the physician within a few days. The test may also be used by physicians to track their patients’ immune profiles over time to monitor changes in disease state and/or treatment response.

The SLE-key was launched this summer in limited markets, and to date its results on blood samples from over 160 patients have determined that two in every three (65%), suspected of having lupus on the basis of a positive ANA test, did not have the disease. In a study comprising 500 patients, the test ruled out a diagnosis of SLE with a specificity of 75% and a sensitivity of 94%.

According to David Pisetsky, MD, PhD, professor of Medicine and Immunology at the Duke University School of Medicine, the SLE-key test is valuable addition in the evaluation of a patient thought to have SLE. “Currently, our strategy for considering the possibility of lupus often necessitates many different laboratory tests and even imaging studies,” Dr. Pisetsky said in a news release. “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 developed the test with assistance of some of the top rheumatology experts in the U.S. It uses the company’s iCHIP technology, an in-vitro diagnostic platform with applications that currently range from ruling out a lupus diagnosis to confirming or ruling out brain injury following trauma or sports-related concussions.