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

> **NIH NIH R44** · VERISKIN, INC. · 2021 · $833,460

## Abstract

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.

## Key facts

- **NIH application ID:** 10127607
- **Project number:** 5R44CA250768-02
- **Recipient organization:** VERISKIN, INC.
- **Principal Investigator:** MIRIANAS CHACHISVILIS
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $833,460
- **Award type:** 5
- **Project period:** 2020-03-15 → 2023-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10127607

## Citation

> US National Institutes of Health, RePORTER application 10127607, Clinical performance of hemodynamics-based non-invasive device for skin cancer testing (5R44CA250768-02). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10127607. Licensed CC0.

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