Advanced Skin Cancer Screenings. Research Collaboration

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Advanced Skin Cancer Screenings Research Collaboration Collaboration Opportunities April 2018

Advanced Skin Cancer Screenings Advanced Skin Cancer Screenings (ASCS) are the focus of a research collaboration with Skin Cancer Free, the OHSU Knight Cancer Institute, and DermDetect LLC to advance skin cancer research. Background Melanoma is a potentially deadly form of skin cancer and is most often evident on the skin s surface. Skin Cancer Screening with a total body skin examination is arguably the safest, easiest and possibly the most cost-effective screening test in medicine, yet there is no national consensus regarding its benefit or implementation. Melanoma is now the fifth most common invasive cancer in men and the seventh in women, with an estimated 76,380 new cases in the U.S. in 2016. The average 5-year survival rate is 91.5%, but it varies significantly based on the stage of the disease, ranging from 98.4% for stage IA to 17.9% for stage IV disease, Total body examination is not usually part of the general physical examination performed by primary providers or non-dermatology specialties. The sad fact is that one American dies every 52 minutes from melanoma. Accurate early detection would prevent many of these deaths. The unnecessary, burdensome healthcare expense relating to the treatment of caught late skin cancer can be avoided with early detection. These costs can be as high as seven figures, which in many cases can cripple a self-insured company or paralyze the affected person with co-pays and direct costs. ASCS Collaboration Objectives Provide over 100,000 participants throughout the United States with Advanced Skin Cancer Screening examinations. Expand the availability of skin cancer screenings to people not currently seeing a dermatologist for their skin care or not able to afford the full cost of a thorough skin cancer screening. Support the development and delivery of methodologies and technologies to detect melanoma and other skin cancers earlier. Improve overall skin cancer survival rates, specifically melanoma. Provide support for research and clinical studies to document the effect of early skin cancer screenings. Support and promote efforts that will lead to future health care coverage for early skin cancer screenings by Medicare, Medicaid, and private insurance providers. PAGE 1

ASCS Collaboration Participants OHSU (Oregon Health and Science University), a nationally-ranked public research university and the OHSU Knight Cancer Institute, an NCI-designated Comprehensive Cancer Center. OHSU trained Dermatologists provide analysis and coding of images acquired during the ASCS Examinations to identify and report on areas that may need further examination by a physician. Skin Cancer Free, a 501(c)(3) non-profit corporation sponsoring and funding the ASCS Examinations using donations, corporate contributions, corporate sponsorships, and ASCS Participant individual payments. DermDetect, a highly qualified independent corporation providing a powerful local examination and analysis service that provides ASCS Examinations. They combine the latest imaging and communication technologies to accurately image, analyze, store and review irregularities of the skin. DermDetect Dermographers have been specifically trained and certified to examine human skin, and identify and digitally photograph areas that may need further examination by a physician. Regional Care Physicians. Each ASCS Examination requires at least one physician licensed in the state where the examination is provided as an examination contact point. This Regional Care Physician (RCP) is typically a dermatologist who has agreed to be available as a Participant examination medical resource for any follow-up care or action that may be recommended based on their ASCS Examination Results. The RCP establishes an e-consult agreement with OHSU, and a HIPAA Business Associate Agreement with DermDetect to allow shared access to Participant medical information and examination images and results. Local. Local physicians and dermatologists can become part of the collaboration by providing ASCS examinations to their patients. This allows their patients data to be included in the collaboration plus allows them to extend the benefits of Total Body Photography and Sequential Digital Dermoscopy Imaging (SDDI) to all their patients without having to invest their time or money. What Does an Advanced Skin Cancer Screening Include? An Advanced Skin Cancer Screening is comfortable, pain-free, and takes about 15-30 minutes. It is entirely non-invasive. A DermDetect Dermographer certified by OHSU takes detailed images of any suspicious area on the skin after a total body exam. A standard exam room or private office space with a power plug is all that is required. A Mobile Testing Coach is also available for public events. PAGE 2

Examination Equipment A microderm D200 EVO Dermatoscope is used to do the imaging. This specialized device is relatively new to the U.S. and yet widely used around the world, and has been decorated with several scientific and design awards. It sets new benchmarks in the field of computer-assisted early recognition of skin cancer. Specialized digital Imaging system software is used to document the precise location on a digital Avatar. Clinical photographs from the skin and surrounding area are also digitized. Clinical Imaging & Epiluminescence Microscopy The purpose of Clinical Imaging and Epiluminescence Microscopy is to capture and refer to a baseline of patient images to allow management and tracking of potential changes over time. To do this, the location of each suspicious area on the body is captured and applied to a body avatar, so the areas that are being photographed can be clearly identified. An Epiluminescence Microscopy Image (ELM) is then captured for each area using a spray of alcohol and direct contact with the surface to block out all external light. A computer controlled integrated LED-ring provides bright full daylight spectrum lighting for the precision optical system. Traditional Dermatoscopes or Dermoscopes will typically magnify 10X. The microderm D200 EVO enables 15 200 fold magnification using reflected-light microscopy, where the Dermatocope through computer control manages all incident light reflections on the skin surface and thus allows a better true color insight into the upper skin layers. The microderm D200 EVO provides Clinical Image ELM capture of reflected-light microscopy and clinical images with one hand held optically engineered camera. Expert Dermatologist Review The images and medical history for the participant are electronically transmitted to OHSU for review. An OHSU Expert Dermatologist examines the images and medical history. They electronically code each image with a corresponding marker that is embedded with the image. Green indicates a recommendation for Routine Followup. Red indicates that Immediate Attention with a medical physician. Yellow indicates that an additional ASCS Examination is suggested after a specific time period to determine if changes have occurred and it the lesion needs to be re-coded. A detailed report is produced along with the coded images. A confirmatory or pre-diagnostic opinion is included in the report. PAGE 3

Participant Portal for Notification of Results The ASCS Participant is notified in 1 to 3 days that their examination results are available via a secure Participant Portal. They will be advised in their final report to call the RCP or their personal physician or dermatologist for an appointment if further action is indicated or recommended. The secure digital Participant Portal allows them to see all documents acquired during the examination process, including health histories and other examination documents. It also provides access to the actual DICOM images of the lesions that have been color coded by the Expert Dermatologist, the Avatar showing the location of these lesions, plus both the clinical and epiluminous images for each lesion. The final Expert Dermatologist Report is also included in the Participant Portal. This digital Participant Portal is a unique feature of the ASCS project, and provides a complete inventory of informaton for the Participant, their physician, or for follow-up examinations. It is available for their access, or for subsequent examination results, for 5 years after every examination. Follow-Up: SDDI A primary tactic of the research collaboration is to combine ASCS Examinations and Sequential Digital Dermoscopy Imaging (SDDI) to help find a developing skin cancer at its earliest stages. The digital images taken of a suspect area on the Participant s body during a first examination are digitally stored and compared to images taken later of the exact same area, using the same high-quality technology. The computer automatically sets lighting and zoom levels to match that of the initial exam to guarantee consistency. These digital images are stored in the participant s personal skin image history file, and then can be reviewed and compared looking for changes that have occurred over time. These images, using the latest technologies and recent innovations, not only allow comparison of size and shape, but also precise color. When SDDI is performed using the microderm D200 EVO, all current and previous images are easily displayed for comparison using sophisticated comparison software. This exam can be performed in minutes. PAGE 4

How Can ASCS Examinations Work For Your Practice? Option 1 - Become a Regional Care Physician for the Collaboration. You can be formally associated with this groundbreaking collaboration with Skin Cancer Free and the OHSU Knight Cancer Institute. This will include material you can use in your practice indicating your participation. You can Increase your patient base with ASCS Participants who desire to obtain followup services from you. Option 2 Provide ASCS Examinations for your Patients. You can generate significant passive income while supporting valuable research that may contribute to broader coverage for these examinations in the future. Your current patients can become participants in this collaboration, requiring a minimum amount of your time. It allows you to extend the proven technologies of Total Body Photography and Sequential Digital Dermoscopy Imaging to all your patients without having to invest significant time or money. You can charge your patients for ASCS examinations and pay a discounted rate for the examinations to be done as part of the collaboration. This can not only provide significant passive income for your practice, but also provide a digital inventory of patient images that can be used for follow-up examinations using SDDI. All your patients will benefit from ASCS exams. You can evaluate the latest examination technology and equipment without having to make a significant initial cash investment. The latest and best technology is usually the most expensive. We ve made significant technology, software, testing, and operational investments that would be out of reach for the average practice. You can see it in action in your practice, and decide if the technology is right for your long-term use. We will be able to give you access to the highly specific images that we have taken of suspicious areas and lesions on your patients that we find in our examination. This library of images can be combined with images acquired later for SDDI comparisons. Easy and Practical Steps for Your Practice JUST 100 ASCS EXAMS CAN MEAN $10,000 IN PASSIVE INCOME FOR YOUR PRACTICE. Patients with concerns about skin cancer pay you an examination fee, typically $400. Many centers across the country offer this service using traditional SLR camera technology, and their images are maintained on individual databases with CD image transfer. The ASCS Collaboration is a first as part of a national data-driven study. PAGE 5

You receive a discount on the cost of the ASCS exam. Your patient pays you a fixed amount and you pay a discounted amount for the ASCS examination. Your practice can earn approximately $100 per patient for each examination. Any ASCS Exam that contains RED lesions will be your alert for the need for follow-up care. Your E-consult with OHSU gives you access to the ASCS Exam report and all images for needed follow-up care. Any ASCS Exam that contains YELLOW lesions will indicate a follow-up examination is required at a later time. The Expert Dermatologist will recommend the length of time for a follow up image for comparison. You can also use the microderm D200 EVO Dermatocope and Software in your practice using available Special Group Discount Pricing. There are cart configurations or wall mounted systems. The examination team will also pay you for the use of your examination room for the time used. Schedules can be arranged to access your office at your convenience. Your office staff and the scheduler will work as a team. No long-term agreement is required. You do this for as long as you wish, and participate to the extent that works best for your practice. Be a part of this exiting collaboration by contacting Skin Cancer Free or DermDetect and asking for more information. Use our websites to submit a contact form or call us. We ll give you all the details. Skin Cancer Free, Inc. 949 203-3820 skincancerfree.org/ascs DermDetect, LLC. 800 692-0490 dermdetect.com/ascs OHSU Knight Cancer Institute War on Melanoma ohsu.edu/ascs PAGE 6