Breakthrough Technology

TruScore redefines skin cancer screening with its speed, size, precision and ease of use, bringing forth accurate early detection results for frontline care professionals

Technology - description

The Advantage

Veriskin has developed Dynamic Epidermal CApillary Measurement (DECAM), a novel and proprietary technology to rapidly and objectively assess skin vascular networks. DECAM’s is the world’s first objective, non-visual or impedance-based application for skin cancer assessment – one that will dramatically aid non-dermatologists, e.g. primary care physicians and nurse practitioners, to rapidly, accurately and objectively assess whether skin moles/blemishes are skin cancers or not. Currently, these clinicians have no objective tool or means to rapidly and accurately assess suspect skin lesions. As a consequence, many skin blemishes are incorrectly diagnosed as possible cancers and the patient unnecessarily escalated for further examination/treatment by specialists, or, conversely, early stage lesions are incorrectly assumed harmless, thereby resulting in potentially more costly care and management when correctly diagnosed. The company’s goal is to change this state of affairs by the creation and distribution of an EU and FDA-cleared screening device that enables better decision making by front line care providers (as well as dermatologists) in skin cancer assessment.

The Veriskin Solution

The Veriskin device is a proprietary, non-invasive, low-cost, hand-held unit that aids a non-expert user to rapidly and objectively determine whether a suspect skin lesion is cancerous, eliminating unneeded escalation of care and biopsies. The patent pending technology works by detecting and analyzing force-induced hemodynamic differences between the normal and malignant skin lesions. Veriskin has developed a proprietary artificial neural network-based AI algorithm and protocols to achieve unparalleled screening accuracy in differentiating skin cancer from a variety of benign conditions. The device provides a score of 0 to 100% indicating the probability that the lesion is cancerous. Pilot and still ongoing clinical studies conducted in multiple dermatology clinics in CA, OR, FL, NE, GA and AZ have demonstrated sensitivity >95% and specificity of >60% (800+ biopsy-verified lesions) in screening for clinicaly significant skin cancers. The simple-to-use device is intended to be used as a decision support tool during routine physical examinations by both dermatologists and non-specialist clinicians, e.g. nurse practitioners or primary care physicians (PCPs) and, eventually, consumers.

Angiogenesis - An Early Hallmark of Cancer

The role of pathological angiogenesis in cancer progression has long been recognized 1 2 3. The induction of angiogenesis is generally considered essential to ensure the supply of nutrients and oxygen for malignant tissue growth, invasion, and metastasis. In order for a tumor cell to survive it cannot be more than a few hundred micrometers from the nearest blood vessel 4. Blood vessel structural abnormalities have been shown to reveal underlying disease very early during the onset of disease; for example it has been reported that after arrival of only 60 to 80 of tumor cells to an in vivo host tissue it starts to exhibit atypical changes in vasculature and that these changes extend beyond tumor margins5.

It has been established that skin cancers 6 have a denser capillary network or larger dimensioned vasculature relative to those present in non-cancerous skin or common nevi 7 8 9 10. For example it has been shown that mean vascular counts (MVC) in cutaneous malignant melanoma are up to ~ 324 % higher than in common acquired nevi and ~ 500% higher than in normal skin 11. Similar increases in MVC were also reported for BCC and SCC tumors 7. Moreover, a gradual rise in vascularity with tumor progression was observed offering a basis for early detection, for monitoring efficacy of treatment and prognostic value 12 13. Neovascularization in melanoma has been correlated with poor prognosis, mortality, and elevated rate of relapse 9 14. Measurements of passive blood perfusion using high-resolution laser Doppler perfusion imaging 15 showed significantly elevated blood flow in primary melanoma tumors as compared to dysplastic melanocytic naevi (2.2x) and normal skin (3.6x); increase blood flow was also observed in BCC tumors 15.

Moreover, many sold tumors have highly elevated interstitial fluid pressure (IFP)16-17-18 which is attributed to leaky capillaries, increased resistance to interstitial fluid flow, and impaired lymphatic drainage. IFP in combination with lower venular pressure has been implicated in being responsible for the vessel collapse, the flow stasis and reversal in tumor vasculature 19. Perfusion experiments showed that geometrical flow resistance of tumors is nonlinear function to applied pressure; the flow resistance is significantly higher at lower perfusion pressure and then asymptotically decreases to a constant value at higher pressures 20-21-22; such non-linear flow dependence in tumors is in contrast to a constant flow resistance of normal tissues and has been attributed to viscoelasticity of tumor vessels and to cellular pressure exerted by the surrounding tumor cells 20

Another relevant aspect of microcirculation is pressure-induced vasodilation (PIV) 23 24 25. Locally applied mechanical pressure induces localized cutaneous vasodilation in the human skin (which may be protecting against pressure-induced vascular dysfunction and lesion formation by delaying the occurrence of local ischemia)23 . In contrast, newly developed tumor vessels typically lack smooth muscle cells 19 and are less likely to respond to physical or chemical stimuli; i.e. their ability to actively vasodilate is impaired.
Veriskin’s DECAM technology is using non-invasive, optical measurement of pressure induced cutaneous hemodynamics to detect the above structural and functional vascular pathologies in malignant lesions.

Proprietary Data Analysis Algorithm

A proprietary AI algorithm performs analysis of pressure induced hemodynamic profiles to determine the probability of skin cancer.  In contrast to imaging based methods of the competitors that are ill suited for analysis on non-pigmented lesions due to low information content of image, Veriskin detects both structural and functional vascular abnormalities associated with the cancer-induced angiogenesis which is a well established hallmark of cancer. Higher information content within such measurements coupled with AI-assisted machine learning analysis of the force-induced hemodynamic response provides for rapid, quantitative answers with outstanding sensitivity AND specificity