Extracellular vesicle biomarkers for detecting severity and progression of knee osteoarthritis

Unmet Need

Osteoarthritis (OA) is a chronic degenerative joint disease that can impact the hands, knees, neck, lower back, and hips, leading to pain and restrictive mobility from the breakdown of connective tissue in these joints. OA is the most common form of arthritis and knee OA in particular is estimated to impact 654.1 million people over 40 years of age, globally. In the US alone, knee OA contributes to over $27 billion in healthcare costs. With an aging population, these burdens are only projected to increase. There is currently no cure available for OA. As such, treatment usually focuses on pain reduction and surgical procedures. Early detection and intervention are imperative for minimizing disease progression. However, diagnostic tools for early detection, especially in a non-invasive manner, are not available. There is a need for non-invasive diagnostic tools that can definitively identify OA and facilitate early detection and disease management.

Technology

Duke inventors have developed a set of diagnostic biomarkers for OA. This is intended to be screened for in a minimally invasive manner from patient blood plasma. Specifically, the inventors have identified blood plasma extracellular vesicle (EV) surface markers specific to knee OA severity and progression. These EV surface markers are highly correlated with EVs in the joint synovial fluid that have been implicated in a pathogenic role in OA progression. This has been demonstrated in matched synovial fluid and blood plasma samples from two patient cohorts (total n = 30) with use of untargeted proteomic analyses to identify the biomarkers. These biomarkers are highly predictive of knee OA progression with AUC values of up to 0.95 (an AUC of 1 being the maximum and indicating perfect prediction).

Other Applications

This technology could also be expanded to other forms of arthritis.

Advantages

• Minimally invasive diagnostic tool for osteoarthritis from patient blood plasma
• High predictive accuracy for osteoarthritis severity and progression
• Proactive disease management to decelerate joint degeneration and improve patient outcomes