Spectra- A novel diagnostic device to improve retinal imaging

Project Information

Spectra

Grant agreement ID: 684584

DOI

10.3030/684584

Project closed

EC signature date 18 June 2015

Start date 1 July 2015

End date 31 December 2015

Funded under

• SOCIETAL CHALLENGES - Health, demographic change and well-being

Total cost

€ 71 429,00

EU contribution

€ 50 000,00

Coordinated by

HEALTH INTELLIGENCE LTD
United Kingdom

Periodic Reporting for period 1 - Spectra (Spectra- A novel diagnostic device to improve retinal imaging)

Reporting period: 2015-07-01 to 2015-12-31

Summary of the context and overall objectives of the project

Health Intelligence provide medical software as diagnostic medical devices. We have developed retinal (fundus) photograph analytical software - Spectra, complemented by the lower cost, standalone and portable Spectra Retineye. Spectra is one of only three software packages certified by the English National Diabetic Retinopathy (DR) Screening Programme. It has benefitted screening providers by seamless integration with patient records and ability to monitor over time. Providers reported improved throughput and attendance.
Spectra highlights much more than just DR. In deployments to date, over 50% of urgent eye clinic referrals are for suspected non-diabetic retinopathies. Thus, Spectra detects reliable biomarkers for many conditions. The greatest causes of blindness (after cataracts) are glaucoma, age-related macular degeneration and DR. Spectra can detect early and treatable stages of these diseases, in particular low-pressure glaucoma missed by ocular pressure tests. New markets also exist for diabetic eye screening programmes (DESP) in countries lacking the resources of the UK NHS. Teleopthalmology (enabled by Spectra Retineye) could deliver these.
Both Spectra and Spectra Retineye can deliver economic benefits:
• Reducing need for expensive equipment and highly-qualified staff
• Portability
• Increased footfall in high-street optometrists from eye screening patients
• Easier and lower cost of screening to patients
• Reduced social security costs due to sight loss
Spectra will deliver tremendous social benefits. Preventable, irreversible sight damage will become rarer, reducing sickness and caring burdens. Spectra Retineye, which is eminently adaptable to teleopthalmology will allow more delivery models. These will detect more problems earlier, including the 46% of diabetics who are unaware they have diabetes and thus risk severe sight loss and other health problems until they are identified.
Objectives :
1 Assess market for AMD screening and low-pressure glaucoma screening. Does Spectra perform well enough? Do we compete in terms of price? How big is the market? Go/no-go decision to develop screening capability; ROI>500%
2 Assess diabetic eye screening programmes/examinations in three different countries to determine whether or not Spectra Retineye meets their requirements >1 country selected as target market for Spectra; ROI>500%
3 Review performance of Spectra Retineye in a pilot in Hungary Evaluation report confirming suitability of Spectra
4 Assess market for private healthcare screening. Review and revise business plan for private retinal screening service, possibly as teleopthalmology Go/no go decision to develop private screening offering, in pharmacies, opticians or retail chains; ROI>500%
5 Form consortium for Phase Two application Any partners needed agree to join consortium
6 Produce business plan including refined Spectra specifications, competitor landscape analysis regulatory compliance assessment, IP assessment and ROI for several commercialisation strategies

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

Task 1. Assess market for eye screening. RONIN Data have produced a score for each of 32 different countries and produced a ‘fact book’. We have selected the Netherlands and Spain for introduction based on this, and selected Norway after successfully forming a relationship with a distributor that led to a pilot.
Task 2. In depth review of markets. Ronin carried out in depth research into the Netherlands and Spain, presented in the core report.
Task 3. Pilot review. We present two study reviews, carried out by Goran Petrovski in the core report.
Task 4. Assess markets. We present our findings in our core report. We project achievable sales that make proceeding to Phase 2 attractive.
Task 5. Partner recruitment We will work with Lindcon in Denmark. We have contacted several hundred distributors, and will make targeted contact with eight in the Netherlands and Spain in the next month to recruit partners.
Task 6. Produce business plan. We present this as our core report.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

Current gold standard in eye condition diagnostic technology is optical coherence tomography (OCT). This technique requires expensive equipment (typically >£35,000) and highly trained personnel to operate. It provides the best, most informative, high-definition 3D images. As such it is typically used in referrals when determining treatment routes, or assessing efficacy post-treatment . Costs to patients range from €220 at a private hospital; to €50 as a standalone appointment, or as low as €18 as part of an eye test at some opticians . However, image analysis is often proprietary and so operators rarely share results effectively due to licensing restrictions. Other techniques to assess and image a retina include wide field fluorescein angiography. This is strictly limited to medical settings, as it involves systemic injection of a dye to allow enhanced visualisation of the fundus. Thus, it also carries a high cost, as well as risk of adverse effects, including death. Existing fundus imaging technology is limited. Spectra and Spectra Retineye perform better through being patient and healthcare centred; rather than camera-centred. Enhanced image manipulation, advanced filters, image enhancement techniques, coupled with image annotation and classification and grading of finding support the detection of eye complications. Many competitor products do little more than simply allow a computer to communicate with a fundus camera. Spectra allows increased throughput by incorporating record-feature based grading and classification of eye conditions. This project has demonstrated that Spectra Retineye allows high-performance fundus photography:
• At a fraction of the cost of ‘gold standard’ examination techniques
• At greater speed than existing screening technology
• In remote health delivery scenario (teleopthalmology); rather than central point of care

Screenshot from software package