Background

Rheumatoid arthritis (RA) is an autoimmune disorder characterized by chronic inflammation leading to destruction of joints. It affects around 1-1.5% of the population often leading to disability and exclusion from the active workforce, placing it among the top 10% of the most socioeconomically expensive disorders. Current treatment aims at remission using a treat-to-target approach requiring continuous monitoring of the disease progression to avoid permanent joint destruction and overtreatment. Ninety percent of RA patients can avoid joint destruction if treatment is started within 3-4 months after onset of the disorder. However, early diagnosis is difficult and requires an experienced rheumatologist. About 60% of all referrals to the rheumatologist on suspicion of RA do not suffer from RA.

Technology Overview

RASiRA is a novel diagnostic tool for detection of rheumatoid arthritis. The biochemical fingerprint of tissue is very sensitive to pathological conditions and alterations associated with disorders often precede morphological changes. RASiRA harvests this rich biochemical information from joints by collecting Raman scattered near infrared light, enabling diagnosis at stages where conventional imaging techniques such as X-ray and ultrasonography fails. The technology provides an alternative to the current gold standard of diagnosis including extensive assessment of many joints, health assessment questionnaire, visual analog scores, and blood samples.

Stage of Development

The development of a system for pharmaceutical research applications have been supported for 1.5 years by GlaxoSmithKline and Galvani Bioelectronics as a CRACK-IT project initiated by NC3Rs. The project is expected to continue until March 2023 with a team of two associate professors and two Postdocs.

Experiments using a rodent arthritis model have shown the technique can reveal disorder mediated changes to soft and hard tissue.

To expand the market potential the project is also moving into human applications. A prototype for human applications has been developed and tested.

SDU have established a collaboration with Department of Rheumatology Odense University Hospital.

A protocol for proof-of-concept clinical trial following STARD guidelines are under development. Clinical trial is expected to be executed in fall 2022. We are also investigating a tomographic scanning version of the system for collecting spatially resolved biochemical information.

Benefits

Early diagnosis reducing the risk of permanent joint damage
Assist healthcare professionals in referring patients on suspicion of RA
Non-invasive diagnosis/monitoring based on biochemical information of soft tissue and bone simultaneously
Non-ionizing, harmless near-infrared laser light
Optimizing therapeutical efficacy studies in rodents.
Compact tabletop system
Quantitative

Applications

Can be used by GPs and hospital doctors for early diagnosis and monitoring of disease activity in RA.

Can be used by pharma industry for testing therapeutic efficacy of novel drugs in rodent models of RA.

Opportunity

SDU offer a novel diagnostic/monitoring tool with established proof-of-concept in rodents and a plan for human trials. The technology for pharmaceutical research applications is already in demand as expressed by our current sponsors. SDU seek to mature and validate both applications to expand the IP. SDU are looking to raise funding for additional human clinical studies and follow-up studies. In addition, SDU seek collaboration on developing prototypes and software.

RASiRA: Raman Spectroscopy in Rheumatoid Arthritis

Patents

IP Status

Seeking