Immunovia’s IMMray Differentiates Lupus from Other Autoimmune Diseases, Study Shows

Immunovia‘s IMMray antibody-analysis technology can differentiate systemic lupus erythematosus (SLE) from rheumatoid arthritis (RA), Sjögren’s disease, and vasculitis with an accuracy of more than 90%, according to new research.

Immunovia teamed up with Lund University’s IDEA Center in Sweden to evaluate IMMray as a biomarker that can distinguish between SLE and other autoimmune diseases with overlapping symptoms.

SLE is one of the most difficult autoimmune diseases to diagnose and monitor. It is called “the great imitator” because its symptoms overlap those of other diseases, including RA, Sjögrens, vasculitis, and thyroid and blood disorders.

More than half of SLE patients are initially misdiagnosed, mainly due to ambiguous laboratory test results. Currently, there is no single urinary or serological test available to clinicians to diagnose SLE. Serum is a clear liquid that can be separated from clotted blood.

IMMray’s antibody-microarray-analysis technology can measure immune-system response with a simple blood test. Immunovia hopes it will help doctors do a better job of diagnosing SLE, classifying it, and predicting what its course will be.

As part of IMMray’s development, Immunovia has defined a series of serum and urine biomarkers associated with SLE.

“Exceeding 90% accuracy already in this first differential study clearly demonstrates that IMMray [biomarker] signatures have a great potential in diagnosing SLE with a simple blood test,” Christer Wingren, head of the IDEA Center and Immunovia’s chief technology officer, said in a press release. “Further studies are already planned to verify and validate these first results in larger independent cohorts,” said Wingren, the study’s principal investigator.

“The capability of IMMray biomarker signatures to diagnose SLE and differentiate it from the other autoimmune diseases with an accuracy above 90% is a remarkable breakthrough,” said Mats Grahn, Immunovia´s CEO. “These very convincing results give us the confidence to dedicate more efforts to the autoimmunity to expand the IMMray™ pipeline. In the short term, we will complete ongoing studies, establish collaborations with key opinion leaders and initiate additional clinical studies to further optimize performance and validate these results.”

Immunovia announced in February 2016 that a study had validated IMMray’s ability to help diagnosis SLE. It said it would be expanding the platform to other autoimmune diseases.

“Since IMMray™ biomarker signatures measure the overall immune system response in blood, we have previously been able to distinguish SLE versus healthy individuals with very good results,’ Wingren said. “However, this new study is particularly interesting because we designed it in collaboration with several leading clinicians to test whether we could distinguish SLE from other main autoimmune diseases that have overlapping symptoms.”