mPatch: a rapid test for improving diagnosis and triage of melanoma patients in primary care

皮肤癌是所有癌症中最常见的，对女性和男性的影响几乎相同。病例数量正在迅速增加，包括黑色素瘤，一种最致命的皮肤癌。皮肤癌的诊断方法近年来几乎没有发展，尽管非常主观和低效。目前的诊断方式：初级保健的初步诊断通常是由全科医生进行目视检查，寻找疑似痣或病变的生理异常。如果看起来可疑，全科医生会建议你紧急等待2周，然后找皮肤科医生做更彻底的视觉检查，然后做皮肤活检。在做出最终诊断之前，活检将被送去进行漫长而昂贵的分析。虽然绝大多数黑色素瘤患者（约94%）通过2WW转诊途径转诊，但96%的患者没有黑色素瘤。这会造成不必要的压力和疤痕，对NHS来说也非常昂贵。每年花费在不必要的皮肤癌诊断程序上的费用超过3500万英镑。需要一种新的，较少主观的测试：因此迫切需要新的诊断测试，可以帮助初级保健的临床医生提高转诊的质量。减少不必要的健康人群的数量也有助于减轻皮肤科医生目前的压力。我们的解决方案是为全科医生提供一种新的负担得起的无痛设备，与目视检查一起使用，以获得更明智的诊断。无痛皮肤贴片和24小时内的结果：无痛地贴在可疑皮肤病变附近，我们的皮肤贴片将收集皮肤液体中含有的癌症特异性分子。然后将其送到一个集中实验室进行快速（24小时）分析，类似于对新冠病毒的检测。我们的测试准确度与皮肤活检相当，将帮助全科医生识别那些需要紧急干预的皮肤癌患者。在这个项目中，我们将通过实验证明我们的测试在皮肤科医生已经进行和分析的人体皮肤活检上的可行性和准确性。在开发我们的原型时，我们还将与全科医生和患者团体合作。这是为了确保它被广泛接受，并能迅速纳入NHS目前的皮肤癌诊断途径。

Cancers of the skin are the most common of all cancers and affect almost equally women and men. The number of cases is increasing rapidly, including for melanoma, one of the deadliest forms of skin cancer. The way skin cancers are diagnosed has barely evolved in recent years despite being very subjective and inefficient.How they are currently diagnosed: Initial diagnosis in primary care typically begins with a visual inspection by a GP, looking for physical abnormalities of a suspected mole or lesion. If it looks suspicious, the GP will recommend an urgent 2-week-wait (2WW) referral with a dermatologist who will then do a more thorough visual examination and then do a skin biopsy. The biopsy will then be sent for a lengthy and costly analysis before a final diagnosis can be made. Although the large majority (>94%) of melanoma patients are sent on the 2WW referral pathway, 96% of people sent on this pathway do not have melanoma. This causes unnecessary stress and scarring and is also very costly to the NHS. Over £35 million are spent every year on unnecessary diagnostic procedures for skin cancer only.The need for a new, less subjective test: There is therefore an urgent need for new diagnostic tests that can help clinicians in primary care improve the quality of their referral. Reducing the number of healthy people sent unnecessarily on the 2WW pathway with also help reduce the current pressure on dermatologists. Our solution is to provide GPs with a new affordable and painless device to be used alongside visual inspection for a more informed diagnosis.A painless skin patch and a result within 24h: Painlessly applied near the suspicious skin lesion, our skin patch will collect cancer-specific molecules contained within the skin fluid. It will then be sent to a centralised lab for a rapid (24h) analysis similar to that done for Covid testing. With an accuracy comparable to that of a skin biopsy, our test will help GPs identify those skin cancer patients that require urgent intervention. In this project, we will experimentally demonstrate the feasibility and accuracy of our test on human skin biopsies taken and already analysed by dermatologists. We will also engage with GPs and patient groups when developing our prototype. This is to ensure it is well accepted and can be rapidly included into the current skin cancer diagnostic pathway within the NHS.