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

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.