Developing a remote breast cancer screening service based on FTIR spectroscopy

BACKGROUND: Cancer is the leading cause of death in Europe. Each year, there are ca. 2.7 million new cases and 1.7 million deaths from the disease. Among the different types of cancer, breast cancer is the most commonly diagnosed cancer for women and the leading cause of death in women worldwide. What is more, recent studies have shown that the illness affects increasingly younger age groups - when before, the risk group included women aged 50 to 70, then now women as young as 30 are advised to do regular screenings. The current diagnostic methods include a mammograph and, to a lesser extent, ultrasounds. However, traditional mammography screening has been shown to reduce breast cancer-related mortality only by 20-30% due to its ability to discover only late-stage breast cancers, usually those that are as much as 6-10 years old, which reduces the success rate of treatment considerably. Additionally, mammography screening has several diagnostic limitations, including the abundance of “false positive” results that require special medical attention, the negative impacts of X-ray radiation as well as the high costs of mammography instruments and screens. This high cost also contributes to many local clinics not being able to afford these diagnostic tools, which leaves many preventable cancer cases entirely undiscovered and untreated. Considering that in 2018, ca 2 million breast cancer cases were diagnosed globally with increasingly younger women affected by the illness, this challenge poses a unique opportunity for the European and global cancer screening industry. As such, new breast cancer screening methods based not on X-rays, but on alternative technologies are highly sought after. The proposed project seeks to exploit this opportunity by using Fourier transform infrared spectroscopy (FTIR) in breast cancer screening as a high-potential, but so far unused alternative for detecting breast cancer. The concept is based on detecting molecular changes in women with cancer – specifically, infrared spectroscopy of women’s hair will be used to measure these molecular changes. The proposed innovation is a remote (samples can be collected at home and sent for testing), cost-effective (cost per sample will be several times lower compared to mammographs) and non-invasive method (no discomfort or pain involved) that complements the current mammography practices. The new method will enable greater access to regular cancer screening, help to retake false positive mammograms, indicate breast cancer much earlier than traditional screening methods can and potentially decrease the need for (unnecessary) biopsies. CROSS-BORDER NATURE: For developing the solution, ARS will focus on patient recruitment, sample collection and sample handling and ISM will focus on sample measurement, data analysis and instrument/database development. ARS will thus mainly contribute to this project with the company’s medical expertise, while ISM will focus on finalizing the hair spectrum analyzer based on previous prototypes in addition to project management responsibilities. The main medium for co-offering the service will be the web platform that will also be developed during the project. Once the breast cancer screening solution has been validated and finalized, the partners will be able to start offering the screening service, i.e. ARS will add the service to its portfolio and collect samples from its patients and ISM will conduct sample analyses using its hair spectrum analyzer. Data will be made available on the joint web platform, e.g. also providing feedback to the patient. OBJECTIVES: The overall aim of the project is to develop and prepare for the commercialization of a remote breast cancer screening service based on FTIR (Fourier-transform infrared) spectroscopy. To this end, the partners will focus on conducting clinical trials that will build upon ISM’s initial findings that there is a specific cancer DNA phenotype that can be used as an early predictor of tumour formation in hair. This knowledge will be used to finalize the Portable FTIR Hair Spectrum Analyzer (PFHSA), a diagnostic/screening instrument based on FTIR spectroscopy that will enable to perform remote infrared screening and testing. Completing this technology and building up a web platform will enable to start offering the breast cancer screening service in which ARS will provide the service of collecting samples from its patients and ISM will conduct sample analyses using its hair spectrum analyzer. The resulting data will be made available via the shared online platform. MAIN ACTIVITIES: - Conduct medical trials to collect and analyze a critical mass of hair samples. - Finalize the Portable FTIR Hair Spectrum Analyzer that will enable to perform remote infrared screening and testing. - Develop a cloud-based SaaS solution for analyzing and storing measurement data as well as a web front-end to interact with the end customer. - Develop a secure and scalable process to handle, analyze and store incoming samples of human hair. - Prepare for commercialization, e.g. specifying IPR issues to protect the joint solution, completing a viable business and execution plan for go-to-market, getting the first beta users to sign up for the service, exploring fundraising opportunities etc. - Carry out joint marketing activities, e.g. being visible in the web and at industry events, taking part in relevant pitching events and competitions, mapping potential investors etc.

As the two partners are jointly developing a new type of service that can be offered both in the programme area and beyond, the programme result indicator is achieved. More specifically, an alternative breast cancer screening solution based on FTIR spectroscopy that enables non-invasive remote screening for women's breast cancer will be developed. The second indicator of joint marketing activities will be achieved jointly as the partners will be attending conferences and industry events together, produce shared marketing and promotion materials (incl. a video, booklets, etc.) and also efforts to approach investors and other high-potential stakeholders will be accomplished jointly (see the work package descriptions for more details). The project activities as such are not designed to promote cooperation between other companies. Developing the service jointly between ISM and ARS is, however, expected to open up new business opportunities for the project partners. For instance, ARS will be able to offer a more diverse service profile for interested stakeholders (e.g. national breast cancer screening programs) and ISM could provide sample analyses also for other medical centres.