2017-03-07

Final data from major Swedish study confirms that IMMray™ biomarker microarray differentiates SLE from other autoimmune diseases with 96% accuracy

LUND, Sweden: Immunovia today announced that the large retrospective autoimmune disease study, performed in collaboration with Lund University’s IDEA Centre has been finalized. The study, first reported in January 2017, included 315 blood samples and was specifically designed to assess the effectiveness of IMMray™ blood-based biomarker signatures in differentiating SLE from three other main autoimmune diseases: rheumatoid arthritis, Sjögren disease and vasculitis. There is a clear clinical need for such a test since more than 50% of SLE patients are being initially misdiagnosed, mainly due to ambiguous laboratory test results.

In the first arm of the study, SLE was detected with an accuracy as high as 95% from the RA sample cohort and 99% from the healthy controls. When differentiated from Sjögren Syndrome and vasculitis, the accuracy rates of the IMMray™ biomarker signature were 84% and 99%, respectively. In the second arm of the study, SLE could be differentiated from a pool of samples of all the three other autoimmune diseases with an accuracy of 96%.

Prof. Wingren, PI and Leader of the IDEA Centre at Lund University and Immunovia´s Chief Technology Officer said: “This study shows extremely high values for the differential diagnosis of SLE which has one of the most difficult diagnosis of all autoimmune diseases. Encouraged by these results, we are now proceeding closely with several key opinion leaders on designing the validation of the IMMray™ biomarker signatures in larger retrospective and prospective trials.”

Immunovia´s CEO, Mats Grahn commented: “Not only do these excellent results demonstrate the best differential diagnosis rates to date for SLE, but they further confirm the progress that Immunovia is making in developing our pipeline beyond pancreatic cancer with new IMMray™ biomarker signatures and panels for areas of clear unmet medical need and large market potentials.”

For more information, please contact:

Mats Grahn

Chief Executive Officer, CEO, Immunovia

Tel.: +46-70-5320230

Email: mats.grahn@immunovia.com

About Immunovia  

Immunovia AB was founded in 2007 by investigators from the Department of Immunotechnology at Lund University and CREATE Health, the Center for Translational Cancer Research in Lund, Sweden. Immunovia’s strategy is to decipher the wealth of information in blood and translate it into clinically useful tools to diagnose complex diseases such as cancer, earlier and more accurately than previously possible. Immunovia´s core technology platform, IMMray™, is based on antibody biomarker microarray analysis. The company is now performing clinical validation studies for the commercialization of IMMray™ PanCan-d that could be the first blood based test for early diagnosis of pancreatic cancer. In the beginning of 2016, the company started a program focused on autoimmune diseases diagnosis, prognosis and therapy monitoring. The first test from this program, IMMray™ SLE-d, is a biomarker signature derived for differential diagnosis of lupus, now undergoing evaluation and validation. (Source: www.immunovia.com)

This information is information that Immunovia AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above.

Immunovia’s shares (IMMNOV) are listed on Nasdaq First North in Stockholm and Wildeco is the company’s Certified Adviser. For more information, please visit www.immunovia.com.

About Centre of IDEA, Lund University

Centre of Innovative Decoding of Autoimmunity, or Centre of IDEA, is a new cross-disciplinary research centre at Lund University (LU). The centre performs translational research, going from the “bed-to-bench and back again, to resolve unmet clinical needs within the field of autoimmunity. The overall objective is to perform innovative decoding of autoimmunity, delivering an extended and refined understanding of human autoimmune diseases at a molecular level, as well as setting a novel standard for diagnosis, prognosis, and classification. The centre spans three faculties at LU, including the Faculty of Engineering, Faculty of Sciences, and Faculty of Medicine. The centre, headed by Prof Wingren, is composed of six PIs, each with unique expertise within the field of autoimmunity, bioinformatics and biomarker discovery.

About Lupus:

Lupus is an autoimmune disease in which the body begins attacking its own healthy tissues and organs. Patients with lupus suffer joint and muscle pain, unexplained fevers, hair loss and fatigue, among a number of other puzzling symptoms. A facial rash can appear across the nose and cheeks, though it does not occur in every case. Women are more likely to get it than men, and there’s no definitive cause, though researchers suspect genes may play a role. It’s often triggered by an infection, a particular drug, or even sunlight. There is no cure, though the symptoms, can be managed. Because the symptoms of lupus mimic other rheumatic diseases, it has historically been difficult to arrive at a correct diagnosis. Recent studies showed that as many as 51% of patients with suspected autoimmune or immune disorders are initially misdiagnosed, in part because of ambiguous laboratory test results. Clinicians warn that misdiagnosis of systemic autoimmune diseases can have serious consequences.

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