Development of a non-invasive molecular diagnosis tool for skin-cancer detection

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Skin cancer is the most commonly diagnosed cancer in the UK. Dermatology services receive more urgent referrals for suspected cancer than any other specialty. There are 1M referrals every year to dermatology specialists and only 6% of them are diagnosed with skin cancer. It is recognised that a significant proportion of patients are seen with non-relevant skin lesions. This creates excessive, unnecessary, and costly referrals to NHS specialists who are already overloaded.Post COVID-19 pandemic, many patients were assessed remotely, and the waiting times increased over 2-weeks. Therefore, the British Association of Dermatologists called for the use of new technology and remote consultations to reduce the need for unnecessary hospital attendances.Molecular diagnostics can drastically help with this problem. The use of at-home skin sampling testing kits followed by molecular diagnosis of skin lesions can reduce dermatologist referrals and enable tele-dermatology practices.In 2020, NHS begun to pilot Grail's blood test that detects 50 types of cancers. In 2021, NHS trails vaginal-swab home-testing kits to improve cervical-cancer screening. Both tests use epigenetic biomarkers to detect early signs of cancer.Epigenetic modifications are chemical marks on the DNA that affect gene expression. They are tissue specific and influenced by the environment. These are the best biomarkers for early cancer detection, however to date, invasive skin biopsies are needed for skin epigenetic analysis.MitraBio has invented a non-invasive skin sampling method (SkinPatch) to detect epigenetic profiles. MitraBio already validated the SkinPatch, showing \>97% corelation in DNA-methylation data compared to biopsies. Reproducibility was measured in \>400 healthy subjects. This resulted in a patent filed July 2021\.During this project, MitraBio is evaluating the clinical use of MitraBio SkinPatch for skin cancer stratification. This includes is a non-interventional observational study aiming to build the stratification tool and validate it in patients who are routinely referred for skin biopsy at Guy's Hospital. MitraBio will collect non-invasive samples before biopsy and histopathology analysis, not intervening in the patient's proposed care.Epigenetic biomarkers have the possibility of predicting precancerous disease progression in patients under follow-up, thereby providing additional valuable information to clinicians. For the patients, MitraBio's solution leads to patient's convenience by avoiding unnecessary surgery and stress.