Veriskin, Inc. — Department of Health and Human Services SBIR Phase II: NCI

Description

DESCRIPTIONprovided by applicantSkin cancer is the most common form of cancer in the USeach year accounting for just under half of all diagnosed cancersmillion diagnosesanddeaths with annual treatment costs of at $billionEarly and accurate diagnosis of skin cancer has significant impact on patient outcomes and health care costs but remains a highly subjective skillwith existing diagnostic devices either offering limited positive predictie value or requiring highly specialized trainingMis diagnoses results in missed skin cancers as well as large numbers of unneeded referrals to dermatologists and unnecessary biopsiesWe have been developing a novel method and device for a fast and non invasive detection of skin cancer based on measurements of the temporal dynamics of pressure induced blood flow in the cutaneous tumorsThe central hypothesis of proposed research is that the dynamics of blood flow in response to external mechanical pressure is different in cutaneous tumors as compared to benign nevi thus presenting a diagnostic opportunityMultiple studies have shown that skin cancer is significantly more vascularized than normal skin or benign nevi while the morphology of tumor vascular network is highly irregular contributing to changes in vascular resistance to blood flow and highly elevated interstitial fluid pressureThe proposed method relies on measuring the spatially and temporally resolved light absorption in the cutaneous tumor tissue using an optical probe which also acts as pressure application deviceThe method enables to characterize both the amount of blood displaced under pressure and the dynamics of blood displacement and refillOur preliminary data from a pilot clinical study show that both the volume and the rate of the pressure induced blood flow are significantly higher in cutaneous cancer than in benign neviHere we proposeto design and build more advanced devices to perform more detailed investigation of pressure induced dynamics in basal and squamous cell carcinomaand melanoma tumorsto investigate instrumentand physiology dependent factors that affect pressure induced hemodynamics in tumor tissue and to improve our data analysis algorithms in order to optimize sensitivity and specificity of our deviceandto develop and test next generation optimized skin cancer detectorThe long term goal of the project is to develop a simple to use and low cost non invasive skin cancer diagnostic method and device that willfacilitate sensitivespecific and non subjective assessment of suspect skin regions by general practice clinicians and nurse practitionersenable precise targeting of patients for biopsies and or escalation of care andprovide overall reduction in skin cancer treatment costs PUBLIC HEALTH RELEVANCESkin cancer is the most common form of cancer in the USaccounting for just under half of all diagnosed cancers anddeaths each yearprojected numbers forThe annual cost of treating skin cancer in the US was estimated at $billion inThe incidence of skin cancer is rising faster than any other cancer and affectsof those overyears of ageEarly detection has significant impact on patient outcomes and health care costsboth direct and indirectSkin cancers are mainly diagnosed by dermatologists using visual clinical evaluationThis assessment remains highly subjective and results in missed skin cancers as well as a highly variable ratio of benign lesions biopsied to malignancies detectedthe biopsy ratio is as high astofor specialistsAt an average cost of $per biopsyan estimated $billion is spent on skin biopsies each year while the majority of these biopsies prove to be negativeConverselyfailure to spot cancer at an earlymore treat able stage may result in individual treatment costs of well over $VeriSkin will develop a low costnon invasive skin cancer diagnostic method and device that willfacilitate accuratespecific and non subjective assessment of suspect skin regions by general practice clinicians and nurse practitionersenable precise targeting of patients for biopsies and or escalation of care resulting in reduction in the number of unneeded referrals to dermatologists and unnecessary biopsiesandprovide overall reduction in skin cancer treatment costs