Immunovia Release: Company Announces The First Data Exceeding 90% Accuracy In Distinguishing Systemic Lupus Erythematosus (SLE) From Other Autoimmune Diseases In A New Study
LUND, Sweden - Immunovia today announced that the principal aim of a large retrospective study, performed in collaboration with Lund University’s IDEA Centre, has been achieved. The data confirms that IMMray™ biomarker signatures can distinguish Systemic Lupus Erythematosus (SLE) from three other main autoimmune diseases, rheumatoid arthritis, Sjögren’s disease and vasculitis with an average accuracy exceeding 90%. These results are extremely encouraging because the symptoms of SLE mimic other rheumatic, autoimmune diseases leading to more than 50% of the patients being initially misdiagnosed, mainly due to ambiguous laboratory test results. It is estimated that as many as 5 million people suffer from SLE and it may take up to 3 years from symptoms appearing to diagnosis and treatment.
Prof. Wingren, PI and Leader of the IDEA Centre at Lund University and Immunovia´s Chief Technology Officer said: “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. 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. Exceeding 90% accuracy already in this first differential study clearly demonstrates that IMMray™ signatures have a great potential in diagnosing SLE with a simple blood test. Further studies are already planned to verify and validate these first results in larger independent cohorts.”
Immunovia´s CEO, Mats Grahn commented: “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. 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.”
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.
Prof. Wingren, PI and Leader of the IDEA Centre at Lund University and Immunovia´s Chief Technology Officer said: “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. 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. Exceeding 90% accuracy already in this first differential study clearly demonstrates that IMMray™ signatures have a great potential in diagnosing SLE with a simple blood test. Further studies are already planned to verify and validate these first results in larger independent cohorts.”
Immunovia´s CEO, Mats Grahn commented: “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. 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.”
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.