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

Award Number: R44CA250768
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 03/15/2020
PERIOD OF PERFORMANCE END DATE: 02/28/2023

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


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2021	VERISKIN, INC	11839 SORRENTO VALLEY RD STE 923	SAN DIEGO	CA	92121	SAN DIEGO	USA	Cancer Detection and Diagnosis Research	000	2	1/9/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $833,460 )
2021	2021	VERISKIN, INC.	6640 LUSK BLVD STE A206	SAN DIEGO	CA	92121	SAN DIEGO	USA	Cancer Detection and Diagnosis Research	000	2	2/26/2021	NON-COMPETING CONTINUATION	$833,460
														Subtotal = $833,460

Issue Date FY: 2020 ( Subtotal = $1,164,975 )
2020	2020	VERISKIN, INC.	6640 LUSK BLVD STE A206	SAN DIEGO	CA	92121	SAN DIEGO	USA	Cancer Detection and Diagnosis Research	000	1	3/13/2020	NEW	$1,164,975
														Subtotal = $1,164,975

Grand Total All Awards = $1,998,435

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

Award Number: R44CA250768

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 03/15/2020

PERIOD OF PERFORMANCE END DATE: 02/28/2023

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