This Small Business Innovation Research Phase I Project proposes to develop a novel non-invasive diagnostic imaging tool for the early detection of skin cancer. In this project, a controlled temperature stimulus is applied to the suspected lesion and the thermal recovery process is captured with an Advanced Longwave Infrared-imaging and Analysis System (ALIAS) capable of measuring temperature differences < 0.02°C. The underlying hypothesis of this approach is that the dynamic temperature response of malignant cells will be different from that of the surrounding normal skin cells due to heat generation caused by abnormal processes such as cell proliferation and thermal diffusion, increased metabolism and excess blood flow. The Phase I effort will involve a pilot study to develop a quantifiable metric to capture the differences in the temperature curves and investigate whether malignant lesions such as Basal Cell Carcinoma (BCC), Squamous Cell Carcinoma (SCC) and Malignant Melanoma (MM) can be distinguished from benign lesions using this metric.
The broader impact/commercial potential of this project would be a dramatic reduction in savings to the US health care industry. For millions of people who observe a suspicious lesion on their skin, the only options available today in the dermatology clinic are either a subjective visual test or an invasive biopsy. Since doctors perform biopsies on any clinically atypical lesions to minimize risk, the ratio of benign lesions biopsied to confirmed melanomas is 80 to 1. There is a need for a real-time, non-invasive, pain-free technology that can bridge this gap. The proposed approach is based on a fundamental quantity associated with cancer growth, namely heat generation. Currently, we spend $10.8B/year on skin cancer biopsies in the US along with a project increase of 14% increase annually. If this approach is successful and the number of biopsies can be decreased by a factor of two, it would represent a $5.4B savings to the US health care industry. The NSF SBIR funding will provide a critical bridge funding that will enable the reduction of technological risk to solicit commercial venture capitalist funding.
Summary of Project Outcomes: Skinfrared is developing a non-invasive screening tool for the early detection of skin cancer. As a part of the National Science Foundation Phase I SBIR grant, data from 100 patients were obtained using the Advanced Long-wave Infrared-imaging System (ALIAS) developed by Skinfrared. A sensitivity (ability to diagnose skin cancer) of 97% and a specificity of 78% (ability to rule out skin cancer) was obtained. This demonstrated the feasibility of the ALIAS device in terms of diagnostic accuracy and work flow. The next step in development for 2014 is to further refine the ALIAS device and algorithms, as a part of the NSF Phase II project. A large clinical data set will be collected in 2015 to extensively test the refined ALIAS device in preparation for formal product development, verification and validation and pivotal clinical trials necessary for regulatory submission in 2016. Background: Skin cancers are increasing worldwide, with epidemic levels in North America,In the U.S., a person has a 20% chance of developing skin cancer and risk increases to 50% for those over 65. Skin cancer is unusually complex and difficult to diagnose and clinical practice relies on highly subjective visual methods for detection. As a result, physicians miss 30% of curable melanomas. In addition, the yield of skin biopsies done to diagnose cancer is quite low with 30 benign moles/lesions biopsied for every one melanoma and 3 benign moles/lesions biopsied for each non-melanoma skin cancer. Missing a curable melanoma delays treatment and can lead to metastatic melanoma which has very poor 5 year survival rates and is extremely expensive to treat. The excess biopsies are a source of patient discomfort and a cost burden to payers. Overall, the market is searching for solutions that yield increased accuracy at the point of care without adding cost to the overall system. Existing Solutions: Currently, visual screening and invasive biopsy are the primary screening methods. Visual screening is highly dependent on the skill, training, and bias of the examining physician. Biopsies are considered a reliable diagnostic method but have issues because of patient discomfort and unnecessary expense (in the U.S. 11 of 14.5 million biopsies are benign, costing $160/biopsy). Companies have recognized that existing solutions are not completely addressing the market need and are developing products based on genomics or spectroscopy (visible, optical coherence tomography, fluorescence, near infrared, Raman). The genetic tests are expensive, ranging from $150 to $1,500 per test depending on whether they are a primary screen or an aid to the pathologist. Spectroscopy-based solutions suffer from either high device cost ($60,000+) or marginal accuracy that does not improve clinical decision making. Technology: The Skinfrared advanced long wave infrared analysis system (ALIAS) uses dynamic infrared imaging to noninvasively determine if a suspicious skin lesion is cancerous. Skin cancer cells are characterized by higher metabolic activity and more blood supply than normal skin cells and as a result have a different thermal recovery profile. In practice a dermatologist or primary care physician identifies suspicious lesions on the patient’s body and uses the ALIAS device to more accurately determine if a given mole/lesion is cancerous. The physician places a registration patch around the suspicious lesion and the ALIAS device is pointed at the registration patch. The device then cools the skin surface, defines the visible boundary of the lesion and measures the thermal recovery profiles of the lesion and surrounding tissue using a long wave infrared camera. Once the thermal profiles are acquired, the ALIAS device calculates a skin cancer risk score also known as a SKI factor. The physician interprets the thermal profiles and SKI factor to determine if the lesion is cancerous and in need of biopsy or removal. Value Proposition: The Skinfrared ALIAS device will address the need for increased diagnostic accuracy at the point of care by providing a moderate cost system (<$7,500/device, < $20/test) that has exceptional sensitivity (95%) and specificity (> 60%) for detecting skin cancer. ALIAS will be easy to use and will fit into established physician office work flows. ALIAS will enable healthcare professionals to make more informed biopsy and lesion removal decisions and also facilitate monitoring of suspicious lesions over time. The ALIAS thermal images and corresponding SKI factor will provide pathologists evaluating skin biopsies with additional information, reducing the number of indeterminate and incorrect diagnoses. For more information, contact: Dr. Sanchita Krishna, PI, Skinfrared LLC 505-504 6846 sanchita@skinfrared.com
