moletest Update for TDUF Meeting on 28 Aug 2014

Moletest App Moletest harnesses the camera and fast processing capabilities of the iPad Mini to capture and analyse images of pigmented skin lesions. It a medical device designed as a diagnostic aid to help GPs improve patient management. Moletest aims to greatly reduce referrals that are later found to be benign in two ways: Providing an immediate, reliable assessment of the risk of malignancy. Enabling review of any changes in a suspect lesion through recalling the patient and comparing both images and risk assessment. Once deployed, fewer patients will have to wait and worry as more benign lesions will be filtered out at an early stage.

Using Moletest App Test Report & Action Compare Comparison Report

Performance Since the last TDUF meeting in December 2013, many improvements have been made: We have made a breakthrough in detecting the border of the pigmented skin lesion. This far greater accuracy has reduced the range of results for all characteristics. Asymmetry has been replaced by a measure of edge irregularity to provide better differentiation. Results for all characteristics are now combined into Malignancy Risk High/Medium/Low output. Moletest has released and evaluated 20 versions of the App in the last year. Originally Moletest used a conventional image processing algorithm to detect the edge of the pigmented skin lesion. However, as many lesions do not have a clearly defined border, the analysis was often compromised as it included areas of surrounding skin. A technical innovation by Moletest has significantly improved the accuracy in detecting the border. Moletest had used a measure of Asymmetry as this is conventionally used to assess the risk of abnormality in a skin lesion. Results presented at the last TDUF meeting showed that this produced poor differentiation. We have developed a method for measuring the irregularity of the edge of the skin lesion. This is far better a distinguishing characteristics that indicate malignancy.

Improved Performance Differentiation between Melanoma, BCC and Benign Analysis Scale of 1 to 10 shows Low Malignancy Risk > 2.3 based on 144 library images These preliminary results are on a small sample size - 144 from mixed library source images. However, there is a clear improvement in performance based on the same data set from previous version - which itself was an improvement on the version demonstrated at the last TDUF Meeting in December 2013.

Report & Action Page This page has been revised and will appear in the next version of the App

Pilot Testing A pilot test within a Clinical Environment has been designed with the help of Dr Girish Gupta and colleagues in Lanarkshire NHS. The test will measure performance of the iPad Mini as an image capture device. The test will also calibrate the differential diagnosis capabilities of the Moletest App. 1,200 participants will be recruited from patients referred from Primary Care. Normal clinical processes will remain unchanged and the output from the App will be anonymous. Moletest would welcome involvement by other Scottish regions.

Adoption by the Digital Health Institute (DHI) In July, Moletest was adopted by the Digital Health Institute as a ‘Factory’ project. The Digital Health Institute is sponsoring our Clinical Pilot Test as a first stage in a process to develop and exploit Moletest for Scotland. Moletest can help patient management, increase efficiency and reduce costs. Scotland’s NHS is facing a major crisis due to the pressures of an ageing population. Efficiency must improve by over 35% to maintain current standards of care for increasing numbers and requirements. Scotland’s health and care budget will need to make equivalent efficiency improvements of £3.5bn per annum.

CE Registration In May this year, MHRA placed Moletest onto its register for: MEDICAL DEVICES REGULATIONS 2002: REGULATION 19 Class I Devices: Dermatological Differential (Calculator) Diagnostic Aid This enables Moletest to use the CE symbol. CE marking is required in order to make sales in 27 European countries. It is also accepted by a growing number of other countries. Moletest will begin the process of applying for FDA approval in September.

FDA Approval Next month Moletest will begin the process for seeking FDA approval based on the MHRA documentation and results generated by the Clinical Pilot Study.