Clinical performance of hemodynamics-based non-invasive device for skin cancer testing

皮肤癌是美国最常见的癌症，占所有确诊癌症的不到一半 癌症(500多万例诊断)，每年27,000多例死亡，每年的治疗费用超过81亿美元。 皮肤癌的早期诊断对患者的预后和医疗费用有重大影响，但 仍然是高度主观的，需要高度专业化的培训，而现有的诊断设备提供的 阳性预测价值，会导致皮肤癌的漏诊以及大量不必要的 活组织检查。当患者出现可疑皮肤损害时，初始评估中的不确定性 皮肤科医生可能会进行活组织检查，表明不需要后续治疗(假阳性- FP)，而同时未活检的病变可能需要治疗(假阴性-FN) 引起对医疗事故的指控。FPS使患者接受不必要的程序和医疗保健 系统到不必要的成本。FNS导致延迟治疗，损害患者预后，并增加 医疗保健费用。当病人第一次到初级保健中心就诊时，这种诊断问题就会加剧。 由于诊断性能较差而进行练习。在这里，一些患者可能会被不必要地转介到 皮肤科医生，而其他病例则没有被发现。Veriskin的TruScore设备是一种专有的、非侵入性的 低成本，易于使用，支持皮肤癌诊断的手持设备。它迅速而客观地 确定可疑皮肤病变是否为癌变，从而减少FN的数量并减少 需要不必要的活组织检查。该设备提供的分数为0%到100%，表示 恶毒。TruScore的工作原理是检测和分析力引起的血流动力学异常 病理性血管生成是癌症的一个公认的早期标志。初步临床研究表明 &gt；99%的敏感度和94%的特异度区分皮肤癌和各种良性疾病。这个 设备在所有级别的护理中都很有用，但当设备用于 初级保健实践。该项目的具体目标是在更大规模的临床研究中测试该设备。这个 该项目的长期目标是实现这种简单易用、低成本的非 侵袭性皮肤癌诊断方法和设备，其将(1)促进敏感、特异和非主观 由全科医生和护士对可疑皮肤区域进行评估，(2)实现精确 以患者为目标进行活组织检查和/或升级护理，以及(3)提供皮肤癌的总体减少 治疗费用。

Skin cancer is the most common form of cancer in the US, accounting for just under half of all diagnosed cancers (5+ million diagnoses), 27,000+ deaths each year and the annual treatment costs of over $8.1 billion. The early diagnosis of skin cancer has significant impact on patient outcomes and health care costs but remains highly subjective and requires highly specialized training while existing diagnostic devices offer low positive predictive value which results in both, missed skin cancers as well as a large number of unnecessary biopsies. When a patient presents with a suspicious skin lesion, uncertainty in the initial assessment by a dermatologist may lead to biopsies that suggest that no subsequent treatment is necessary (false positive - FP) while at the same time lesions that are not biopsied may warrant treatment (false negative - FN) potentially giving rise to claims of malpractice. FPs subject patients to unnecessary procedures and the health care system to unnecessary costs. FNs result in delayed treatment, compromising patient outcomes and increasing health care costs. This diagnostic problem is exacerbated when a patient first presents to a primary care practice due to lesser diagnostic performance. Here, some patients may be referred unnecessarily to dermatologists while other cases go undetected. The Veriskin’s TruScore device is a proprietary, non-invasive, low-cost, easy-to-use, hand-held unit that supports the diagnosis of skin cancer. It rapidly and objectively determines whether a suspicious skin lesion is cancerous, reducing the number of FNs and also reducing the need for unnecessary biopsies. The device provides a score of 0% to 100% indicating the probability of malignancy. The TruScore works by detecting and analyzing force-induced hemodynamic abnormalities due to pathological angiogenesis which is a well established early hallmark of cancer. Pilot clinical studies indicate >99% sensitivity and >94% specificity in differentiating of skin cancer from a variety of benign conditions. The device is useful at all levels of care, but the greatest benefits to patients may result when the device is used in primary care practice. The specific goal of this project is to test the device in a larger scale clinical study. The long-term goal of the project is to achieve widespread clinical adoption of this simple-to-use and low-cost non- invasive skin cancer diagnostic method and device that will (1) facilitate sensitive, specific and non-subjective assessment of suspect skin regions by general practice clinicians and nurse practitioners, (2) enable precise targeting of patients for biopsies and/or escalation of care and (3) provide overall reduction in skin cancer treatment costs.