Pivotal Clinical Study of the TruScore Device for Non-Invasive Skin Cancer Diagnostics

皮肤癌是美国最常见的癌症，有500多万例诊断，超过27，000人丧生 每年的治疗费用超过80亿美元。皮肤癌的早期诊断具有重要意义。 并且对患者结果和治疗成本产生积极影响，但仍然具有高度主观性， 只有皮肤科医生才能接受的专业培训。目前批准的诊断设备具有低 诊断准确性，这阻碍了临床医生的任何重大采用。当患者出现 可疑的皮肤病变，皮肤科医生最初评估的不确定性往往导致活检， 提示没有后续治疗是必要的，而一些没有活检的病变确实需要紧急治疗， 治疗假阳性使患者遭受不必要的侵入性手术（疤痕和伤口的危害 感染），减少提供者对其他需要更紧急治疗的患者的可及性， 不必要的费用。假阴性导致治疗延迟、患者不良结局和 可避免的医疗费用。当患者第一次出现在原发灶时， 由于诊断准确性低得多，护理实践;在这里，一些患者被不必要地转诊到 皮肤科医生，而许多皮肤癌未被发现。总体而言，缺乏准确、客观的评估 为一线提供者提供的工具导致了可预防的生命损失，并使美国医疗保健系统的成本超过30亿美元 年;不必要地浪费的钱。Veriskin的TruScore设备是一种专有的，非侵入性的，低- 价格低廉，易于使用，手持设备，支持皮肤癌的诊断。它迅速而客观地 确定可疑皮肤病变是否为恶性。该装置提供0至100的评分，指示 恶性肿瘤的可能性TruScore设备的工作原理是检测和分析由力引起的 由于病理性血管生成导致的血液动力学异常，这是一个公认的早期标志， 癌初步临床研究表明，在区分皮肤癌和乳腺癌方面，敏感性>99%，特异性>94%。 各种良性病变TruScore设备已被授予FDA突破性设备称号 2020年的状态。该设备将在所有级别的护理中使用，但可能会给患者带来最大的好处 当该装置用于初级保健实践时。该项目的具体目标是进行一项关键的临床研究， 试验并获得FDA对TruScore器械的上市前批准，用于初级保健和 皮肤科实践。 该项目的长期目标是实现临床广泛采用的简单易用和低成本 用于皮肤癌检测的非侵入性设备，其将：（1）通过促进更多的 由非专家临床医生对可疑皮肤区域进行准确和非主观的评估，（2）能够精确地 针对患者进行活组织检查和护理升级，以及（3）降低皮肤癌治疗成本。

Skin cancer is the most common form of cancer in the US with 5+ million diagnoses, over 27,000 lives lost each year and the annual treatment costs of over $8 billion. The early diagnosis of skin cancer has a significant and positive impact on patient outcomes and treatment costs but remains highly subjective and requires highly specialized training that only dermatologists receive. Currently approved diagnostic devices have low diagnostic accuracy which has prevented any significant adoption by clinicians. When a patient presents with a suspicious skin lesion, uncertainty in the initial evaluation by a dermatologist often leads to biopsies that suggest that no subsequent treatment is necessary while some lesions that are not biopsied do require urgent treatment. False positives subject patients to unnecessary, invasive procedures (harms of scaring and wound infections), reduce provider’s accessibility to other patients needing more urgent treatments and the health care system to unnecessary costs. False negatives result in delayed treatment, adverse patient outcomes and avoidable health care costs. This diagnostic problem is exacerbated when a patient first presents to a primary care practice due to much lower diagnostic accuracy; here, some patients are referred unnecessarily to dermatologists while many skin cancers go undetected. Overall, the lack of accurate, objective assessment tool for frontline providers leads to preventable loss of lives and costs the US healthcare system over $3B each year; monies that are unnecessarily wasted. 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 malignant. The device provides a score of 0 to 100 indicating the probability of malignancy. The TruScore device 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 lesions. The TruScore device has been granted FDA’s Breakthrough Device Designation Status in 2020.The device will be 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 perform a pivotal clinical trial and receive FDA’s premarket approval for the TruScore device for use in both, primary care and dermatology practices. The long-term goal of the project is to achieve widespread clinical adoption of the simple-to-use and low-cost non-invasive device for skin cancer detection that will: (1) improve patient outcomes by facilitating more accurate and non-subjective assessment of suspect skin regions by non-expert clinicians, (2) enable precise targeting of patients for biopsies and escalation of care and (3) reduce skin cancer treatment costs.