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.

Grant Number: 5R44CA203038-06
NIH Institute/Center: NIH
Principal Investigator: MIRIANAS CHACHISVILIS