Swedish firm Immunovia has reported positive results from a new clinical study of its IMMray blood test to detect patients with rheumatoid arthritis (RA).
Conducted in alliance with Linköping University, the study showed that the IMMray test could identify patients who tested negative with antibodies against cyclic citrullinated peptides (CCP ).
While anti-CCP negative RA patients represent 25-30% of total cases, the condition is said to be missed by the current gold standard assay.
The study recruited 122 patients who tested sero-negative for rheumatoid factor (RF) and anti-CCP, along with 94 healthy participants as controls.
Apart from these subjects, the investigators also tested 367 RA patients who were anti-CCP or RF-negative, or positive to both.
Findings revealed that the IMMray test was more than 90% accurate for all RA patients.
Immunovia CEO Mats Grahn said: “The capability of IMMray biomarker signatures to diagnose CCP negative patients with accuracy over 90% is, in fact, a remarkable breakthrough. These very convincing results give us the confidence to also focus on autoimmunity and CCP negative RA.”
Grahn added that the company will work towards designing additional studies to validate the results and begin development of the assay for commercial use.
IMMray is a platform of antibodies and advanced bioinformatics such as machine learning algorithms that can isolate relevant biomarkers.
The test’s biomarker signatures are said to facilitate differentiation of various autoimmune diseases characterised by overlapping clinical symptoms.
Linköping University Clinical and Experimental Medicine department professor Thomas Skogh said: “This novel study is particularly interesting since, until now, we have been unable to detect the significant number of RA patients not identified by anti-CCP testing.
“Exceeding 90% accuracy already in this preliminary study clearly indicates that IMMray signatures have a great potential to diagnose and help managing autoimmune diseases by the aid of a simple blood test.”
Previously, the IMMray test was able to distinguish systemic lupus erythematosus (SLE) patients from those suffering from RA or Sjögren’s syndrome.