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Pivotal Clinical Study of the TruScore Device for Non-Invasive Skin Cancer Diagnostics

Award Number: R44CA203038
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 05/01/2016
PERIOD OF PERFORMANCE END DATE: 06/30/2025

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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.


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 = $742,845 )
2024	2024	VERISKIN, INC	11839 SORRENTO VALLEY RD STE 923	SAN DIEGO	CA	92121	SAN DIEGO	USA	Cancer Detection and Diagnosis Research	000	6	7/16/2024	NON-COMPETING CONTINUATION	$742,845
														Subtotal = $742,845

Issue Date FY: 2023 ( Subtotal = $726,013 )
2023	2023	VERISKIN INC	10211 PACIFIC MESA BLVD	SAN DIEGO	CA	92121	SAN DIEGO	USA	Cancer Detection and Diagnosis Research	001	5	6/21/2023	NON-COMPETING CONTINUATION	$757,314
2023	2018	VERISKIN INC	10211 PACIFIC MESA BLVD	SAN DIEGO	CA	92121	SAN DIEGO	USA	Cancer Detection and Diagnosis Research	000	3	10/1/2022	SUPPLEMENT FOR EXPANSION	-$31,301
														Subtotal = $726,013

Issue Date FY: 2022 ( Subtotal = $1,499,425 )
2022	2022	VERISKIN, INC.	10211 PACIFIC MESA BLVD STE 404	SAN DIEGO	CA	92121	SAN DIEGO	USA	Cancer Detection and Diagnosis Research	000	4	7/14/2022	COMPETING CONTINUATION	$1,499,425
														Subtotal = $1,499,425

Issue Date FY: 2020 ( Subtotal = $0 )
2020	2017	VERISKIN, INC.	6640 LUSK BLVD STE A206	SAN DIEGO	CA	92121	SAN DIEGO	USA	Cancer Detection and Diagnosis Research	000	3	6/16/2020	NON-COMPETING CONTINUATION	$0
2020	2017	VERISKIN, INC.	6640 LUSK BLVD STE A206	SAN DIEGO	CA	92121	SAN DIEGO	USA	Cancer Detection and Diagnosis Research	002	3	7/10/2020	NON-COMPETING CONTINUATION	$0
2020	2017	VERISKIN, INC.	6640 LUSK BLVD STE A206	SAN DIEGO	CA	92121	SAN DIEGO	USA	Cancer Detection and Diagnosis Research	001	3	6/16/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2019 ( Subtotal = $0 )
2019	2017	VERISKIN, INC.	6450 LUSK BLVD SUITE E202	SAN DIEGO	CA	92121	SAN DIEGO	USA	Cancer Detection and Diagnosis Research	000	3	1/25/2019	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2018 ( Subtotal = $2,000 )
2018	2018	VERISKIN, INC.	6450 LUSK BLVD SUITE E202	SAN DIEGO	CA	92121	SAN DIEGO	USA	Cancer Detection and Diagnosis Research	000	3	8/8/2018	SUPPLEMENT FOR EXPANSION	$2,000
														Subtotal = $2,000

Issue Date FY: 2017 ( Subtotal = $896,929 )
2017	2017	VERISKIN, INC.	6450 LUSK BLVD SUITE E202	SAN DIEGO	CA	92121	SAN DIEGO	USA	Cancer Detection and Diagnosis Research	002	3	5/1/2017	NON-COMPETING CONTINUATION	$896,930
2017	2016	VERISKIN, INC.	6450 LUSK BLVD SUITE E202	SAN DIEGO	CA	92121	SAN DIEGO	USA	Cancer Detection and Diagnosis Research	001	2	1/18/2017	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$521,409
2017	2016	VERISKIN, INC.	6450 LUSK BLVD SUITE E202	SAN DIEGO	CA	92121	SAN DIEGO	USA	Cancer Detection and Diagnosis Research	000	1	1/13/2017	NEW	-$521,410
														Subtotal = $896,929

Issue Date FY: 2016 ( Subtotal = $977,245 )
2016	2016	VERISKIN LLC	4744 KESWICK CT	SAN DIEGO	CA	92130	SAN DIEGO	USA	Cancer Detection and Diagnosis Research	000	1	4/27/2016	NEW	$977,245
														Subtotal = $977,245

Grand Total All Awards = $4,844,457

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Pivotal Clinical Study of the TruScore Device for Non-Invasive Skin Cancer Diagnostics

Award Number: R44CA203038

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 05/01/2016

PERIOD OF PERFORMANCE END DATE: 06/30/2025

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