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Alzheimer’s Disease Diagnosis by Spectroscopy. Accurate and Non-Invasive Medical Device for the Diagnosis of Early Stage Alzheimer's Disease.

Periodic Reporting for period 1 - ADiRaS (Alzheimer’s Disease Diagnosis by Spectroscopy. Accurate and Non-Invasive Medical Device for the Diagnosis of Early Stage Alzheimer's Disease.)

Reporting period: 2015-07-01 to 2015-10-31

ADiRaS is a technique designed for non –invasive diagnosis of early stage Alzheimer’s disease. We have incorporated for the first time the use of Raman Spectroscopy to develop a revolutionary diagnosis device through the analysis of blood plasma sample. Our main objective is to promote, industrialize and commercialize our device among hospitals to become a reference diagnostic method for routine screening of Alzheimer’s patients.

Currently, AD is diagnosed with a comprehensive set of tests, including questionnaires and clinical interviews with patients in order to assess impairment and behavioral changes. However, these tests are inconclusive, as symptoms of different dementia types are easily misdiagnosed or conflated with the normal aging process. For these reasons, these tests need to be supplemented with diagnostic imaging tests such as Positron Emission Tomography (PET). PET scans the patient’s brain after being injected with a radioactive marker, which can cause major allergic reactions. Another method analyzes the cerebrospinal fluid, which requires performing the patient a lumbar puncture. This procedure can cause severe headaches, temporary pain of numbness to legs, infections and bleeding into the spinal canal. On the contrary, our solution consists of performing RS onto a sample of blood plasma. It is not invasive and has absolutely no side effects.

Alzheimer’s Disease and Diagnostic Market was valued in €7,1bn in 2012. The aging population, the increasing prevalence and it’s strong R&D pipeline makes this sector dynamic and promising to introduce ADiRaS test. First, due to its cost effectiveness and noninvasive nature, ADiRaS can be easily adopted by hospitals to provide an accurate diagnostic to their patients. In other words, to promote early and definitive diagnosis in individuals with memory impairment.

The information provided in Phase 1 was preliminary and during this feasibility study we have analysed our business case carefully and confirmed our estimations. During this stage, we have arrived to the conclusion it is worth continuing to the Phase 2.
Technical Feasibility: We have tested our diagnosis algorithm extending our study from 200 to 400 samples. This provided ADiRaS with a greater statistical power that we will use to show to our potential clients as a strong evidence of our product efficiency.

Freedom to Operate Analysis: We have conducted a study regarding all devices based on Raman Spectroscopy, which analyzes human tissue or blood plasma samples to diagnose AD or any other diseases. We have found 6 patents that needed to be studied in detail. Despite the fact that none of the patents deals with all the important aspects of ADiRaS device, certain aspects may enter into the scope of our work and therefore, they were properly assessed. We concluded that there is no conflict with any of the patents obtained and therefore we will be able to operate freely.

Commercial and Financial Feasibility: We have analyzed our user’s needs and we have estimated the best way to reach them. We have identified 3 targeted users and for each of them, we have established the best route market ADiRaS.

Moreover, we have determined our geographical markets of interest. We will start commercializing ADiRaS in Spain, France and Belgium. Subsequently, we will continue to expand to Germany, UK and Italy. Finally, we plan to reach the US.

We have also studied the regulatory path and established the tasks required to affix the CE mark to our device and to obtain FDA approval, as they are required to commercialize freely in Europe and the US, respectively.

Finally, we have developed a business plan where we have estimated the cost and per-unit sales price as well as the units to be sold annually. We have considered 3 different scenarios, including 3 perspectives: a pessimistic, a realistic and optimistic approach. In all 3 cases, even in the pessimistic scenario, investments founds are recovered before 2019. This clearly shows that our project is financial and commercial viable.
Currently, about 16% of the European population is over 65 years old. More importantly, this figure is expected to reach the 25% by 2030 and 50% by 2050 of the total European population. By 2050, 1 in 3 people will suffer from AD. Currently in Europe, AD affects about 800,000 new patients every year, and the total medical and social cost of AD in Europe is close to €135 bn. There is a huge number people in Europe that have not received a diagnosis (7,4 million), mostly due to a lack of recognition of the symptoms or their severity (61%). Early diagnosis and intervention is cost-effective, improves the quality of life of the patient and reduces total care expenditures by delaying the entry of the patient to a nursing home. Early diagnosis and treatment can reduce the total costs by maintaining the patients’ functional level, and reducing morbidities and related hospital admissions. Delaying entry to care institutions by providing early diagnosis and treatment could produce net savings of €10,000 per patient, and a total of €2.8 bn for the European Healthcare system. We are proposing a solution that will save the European healthcare system €7.4 million in care institution costs alone.
Publishable Summary's associated images: Project 683708 (ADiRaS)