Exosome Diagnostics, a Bio-Techne Corp. brand, presented initial data on their novel non-invasive saliva profiling assay for Sjögren’s Syndrome diagnosis and monitoring.

The data was unveiled at the 15th International Symposium on Sjögren’s Syndrome in Rome, Italy on Sept. 9, 2022. Exosome Diagnostics’ novel Sjögren’s Syndrome diagnostic and monitoring tool leverages extracellular vesicles (EVs) to monitor the RNA transcriptome from a small saliva sample.

The data presented highlights a non-invasive monitoring tool to diagnose and understand the pathogenesis of Sjögren’s Syndrome from a small saliva sample, with potential applications for other autoimmune diseases.

The presentation, “Identification of a saliva exosomal-RNA signature for Sjögren’s Syndrome,” was given by Exosome Diagnostics study collaborator Athena Papas, DMD, PhD, FACD, professor of diagnostic sciences at Tufts School of Dental Medicine. The study included saliva from Sjögren’s Syndrome patients as well as from other autoimmune disease patients, including systemic lupus erythematosus and rheumatoid arthritis, as well as necessary controls.

Sjögren’s Syndrome is a hard to diagnose autoimmune disease, with impacted patients often on a several year journey before being properly diagnosed, creating a high need for a non-invasive, accurate molecular test. Exosome Diagnostics’ saliva EV-based assay has proven to not only being able to stratify these patients, but also profile the molecular pathways that are affected in each patient.

Historically it has been challenging to monitor RNA in saliva but by using the Exosome-based platform, over 12,000 mRNAs were profiled in these samples. The area under the Receiver Operating Characteristic Curve (AUC) values were over 0.9 for identification of Sjögren’s Syndrome patients, and identified novel pathways affected in these patients as well as well-known pathways targeting interferon responses and aquaporins.

“We believe this is a very important step forward to enable precision medicine using saliva as the basis for a completely non-invasive liquid biopsy. New tools for diagnosing and monitoring auto-immune disease patients, including Sjögren’s Syndrome, are important to improving patient care. Additionally, being able to shed light on what molecular pathways are affected could increase the understanding of the heterogeneity of these diseases, and ultimately lead to more efficient treatment options,” says Johan Skog, MD, chief scientific officer at Exosome Diagnostics.