Immunovia AB (STO:IMMNOV), a manufacturer of healthcare devices, on Tuesday announced an update on its Rheumatoid Arthritis (RA) pipeline project under which the Immunovia's IMMray shows an accuracy of higher than 90% when diagnosing CCP negative rheumatoid arthritis patients, compared to healthy controls.
The company stated that unprecedented results prompted it to make a strategic decision to focus on RA as one of its pipeline projects. RA is one of the largest autoimmune diseases affecting approximately one in every 100 people globally. The patients with advanced RA, when diagnosed with the anti CCP test which is the current golden standard fall into two categories. One is where 70% are 'seropositive' and other where 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.
Immunovia has built a Key Opinion Leader (KOL) network that supports the design of its RA programme 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. This study is building upon the first study and uses Immunovia's IMMray platform technology and is designed to mirror the clinical situation where such a test would be clinically used.
In addition, Immunovia announced that it 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. This research will be led by Prof. Dr Thomas Huizinga, a world renowned KOL in RA diagnosis and research.
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