Unprecedented results prompted Immunovia to make a strategic decision to focus on RA as one of the company's pipeline projects. RA is one of the largest autoimmune diseases affecting approximately 1 in every 100 people globally. The patients with advanced RA, when diagnosed with the anti CCP test which is today's golden standard fall into two categories: 70% are "seropositive" and 30% are "seronegative" because they are incorrectly classified as not having RA. There is a strong and growing trend in healthcare towards earlier detection of RA, since that would not only significantly improve patient outcome but would present a cost savings to society. The global market for RA testing continues to grow and is estimated to reach € 2.5 billion by 2024.

Update on Immunovia's RA Program:

Immunovia has built a Key Opinion Leader (KOL) network that supports the design of its RA program and will be the source of fresh, high quality blood samples for the various testing phases, required to bring the test to the market.

The focus of the second retrospective study, in collaboration with Prof. Dr. Thomas Huizinga from Leiden University Medical Center's Rheumatology Department, is to differentiate patients with RA from controls that only exhibit RA-like symptoms. The study is building upon the first study and use Immunovia's IMMray™ platform technology and is designed to mirror the clinical situation where such a test would be clinically used.

"We are very pleased with the progress that has been made with this initial step in Immunovia's RA program. Building the KOL network takes tremendous effort and time, especially in the initial phases. It is crucial to have access to the necessary high-quality fresh blood samples that best mirror commercialization environments to test our platform with new indications. Our KOLs are also the first future customers, making this stage of the project very important," stated Mats Grahn, CEO of Immunovia. Mr. Grahn continued, "We look forward to providing continuous updates on this very exciting project."

Collaboration with Leiden University Medical Center's Rheumatology Department:

Immunovia is pleased to announce that the company has entered into collaboration with Leiden University Medical Center's Rheumatology Department, one of the leading research centers on rheumatoid arthritis in Europe.

Awaiting ethical approval, Leiden will then provide biobank samples for a retrospective study that will be used for the next step in developing Immunovia's proprietary IMMray™ RA-d assay.

The goal is to test whether or not Immunovia's IMMray™ platform can differentiate between RA patients, independent of being seropositive or seronegative, and other conditions with similar symptoms like RA. The current standard, CCP diagnosing tests, cannot diagnose the seronegative patients, missing approximately 30% of the RA cases. The research will be led by Prof. Dr. Thomas Huizinga, a world renowned KOL in RA diagnosis and research.

"Innovative diagnostic platforms like IMMray™ will provide physicians the necessary tools to better care for those suffering from autoimmune rheumatic conditions", stated Prof. Dr. Thomas Huizinga. "We are excited for this collaboration and to discover the full potential that Immunovia's IMMray™[ ]can offer."

For more information, please contact:

Julie Silber
Director of Investor Relations

Email: julie.silber@immunovia.com

Tel: +46 7 93 486 277

This is information that Immunovia 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, at 14:15 CET on October 22, 2019.

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.
(Source: www.immunovia.com)

Immunovia's shares (IMMNOV) are listed on Nasdaq Stockholm. For more information, please visit www.immunovia.com.

About Rheumatoid arthritis (RA) 

Rheumatoid arthritis is a long-term condition that causes pain, swelling and stiffness in the joints. The symptoms usually affect the hands, feet and wrists. There may be periods where symptoms become worse, known as flare-ups or flares. A flare can be difficult to predict, but with treatment it's possible to decrease the number of flares and minimize or prevent long-term damage to the joints. Some people with rheumatoid arthritis also experience problems in other parts of the body, or more general symptoms such as tiredness and weight loss. 

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. Currently the gold standard is to test for anti-cyclic citrullinated peptide (anti-CCP), an auto-antibody present an estimated 70-75% of rheumatoid arthritis patients. 

The global market for RA testing is growing strongly and estimated to reach Euros 2.5 billion by 2024.                                

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