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

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 andgt;99% sensitivity and andgt;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.Project Narrative The lack of accurate, objective skin cancer assessment tool for frontline caregivers leads to preventable loss of lives and costs the US healthcare system over $8B each year.VeriSkin device enables a low cost, non-invasive, easy-to-use skin cancer diagnostic method that will (1) facilitate accurate and non-subjective assessment of suspect skin lesions by general practice clinicians, nurse practitioners and physician assistants, (2) enable precise targeting of patients for biopsies and/or escalation of care resulting in reduction in both the number of missed skin cancers and the number of unneeded referrals to dermatologists and unnecessary biopsies, and (3) provide overall reduction in skin cancer treatment costs.The requested funds will be used to demonstrate the safety and the effectiveness of the device in a larger clinical study needed to enable regulatory approval of the device.