Lupus Diagnostic Test to Advance Through Clinical Studies and a New Partnership

Immunovia AB recently announced it has entered into a collaboration with a large multinational life science company to jointly conduct trials to expand the application of IMMray, a technology platform based on antibody microarray analysis, to include autoimmune diseases like systemic lupus erythematosus (SLE). The company was not otherwise identified.

SLE, or lupus, is a systemic autoimmune disease in which the body’s immune system mistakenly attacks healthy tissue. The course of the disease is unpredictable, with periods of illness (flare-ups) alternating with remissions. It is estimated that 5 million people suffer from SLE worldwide, with 100,000 new cases reported every year, increasing the need for accurate and efficient SLE diagnostic tests.

SLE is one of the most difficult autoimmune diseases to diagnose and monitor. The disease is also known as “the great imitator” because its symptoms are similar to other diseases such as vasculitis, Sjögrens syndrome, rheumatoid arthritis, and thyroid and blood disorders. Currently, there is no single serological and/or urinary test available to clinicians to diagnose SLE.

Based on its IMMray technology, Immunovia hopes to provide a blood-based test for differential diagnosis, prognosis, and classification (phenotyping) of SLE, thereby giving clinicians essential treatment information. Immunovia has defined a set of condensed panels of serum and/or urine biomarkers (biomarker signatures) associated with SLE. The panels will be suitable for screening patients with suspected symptoms, for predicting and/or monitoring the risk of flares, and for classifying patients based on minimally invasive blood tests.

Two studies are expected to be completed during 2016. One is a randomized clinical trial of the IMMray SLE-d platform intended to confirm Immunovia’s preclinical test results, and a second will compare the platform’s efficacy in SLE patients compared to patients with similar symptoms but without an autoimmune disease diagnosis.

“This agreement further strengthens and complements the previously announced collaboration in autoimmunity with Lund University and we find the market prospects very attractive,” Mats Grahn, CEO of Immunovia, said in a press release. “We are looking forward to work closely with acknowledged leaders in this challenging field to evaluate and further refine our blood based antibody array for improved SLE diagnosis.”