IMMray, an antibody array technology platform from Immunovia AB, Lund, Sweden, shows an accuracy greater than 90% when diagnosing CCP-negative rheumatoid arthritis (RA) patients, according to a recent study.
Patients with advanced RA who are diagnosed by the anti-cyclic citrullinated peptide (anti-CCP) test that is today’s gold standard fall into two categories: 70% are seropositive, and 30% are seronegative. Current tests cannot diagnose seronegative patients, so they miss approximately 30% of RA cases.
Illustration of the Immunovia chip.
Such positive study results have prompted Immunovia to focus on RA as one of the company’s pipeline projects. Toward that goal, Immunovia has built a key opinion leader (KOL) network to support the design of its RA program and to be the source of fresh, high-quality blood samples for the various testing phases required to bring the test to the market.
The company has also entered into a collaboration with the rheumatology department at Leiden University Medical Center, one of Europe’s leading research centers for rheumatoid arthritis. Pending ethical approval, the department will provide biobank samples for a second retrospective study that will be used for the next step in developing Immunovia’s proprietary IMMray RA-d assay.
The second study, in collaboration with Thomas Huizinga, MD, PhD, head of the rheumatology department at Leiden University Medical Center, will attempt to differentiate among RA patients and patients with other conditions that present similar, RA-like symptoms. The second study will also use Immunovia’s IMMray platform technology and is designed to mirror the clinical situation where such a test would be used.
Mats Grahn, Immunovia.
“We are very pleased with the progress that has been made with this initial step in Immunovia’s RA program,” says Mats Grahn, CEO of Immunovia. “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. We look forward to providing continuous updates on this very exciting project.”
RA is one of the most prevalent autoimmune diseases, affecting approximately 1 in every 100 people globally. It is a long-term condition that causes pain, swelling, and stiffness in the joints. The symptoms usually affect the hands, feet, and wrists. Some people with rheumatoid arthritis also experience problems in other parts of the body or more general symptoms such as tiredness and weight loss. The global market for RA testing continues to grow and is estimated to reach $2.77 billion by 2024.
For further information, visit Immunovia.
