Recent developments within EU in the area of health-care, such as cuts in budgets and higher life expectancy, are pointing cancer and other chronic diseases as an economic and social challenge. Non-personalized treatments, such as chemotherapy, often have low efficacy and serious side-effects worsening patient's quality of life at high costs for the society. In addition, it is not possible to tailor in advance on the single patient the best dosage, duration and period, and monitoring afterwards. This uncertainty is caused by a lack of diagnostic technology and too little insight into the progression of the disease & the efficacy of the therapy. There is therefore a need for improved / earlier diagnosis of metastatic cancer, determining which patients are more likely to die from progression and recurrence of metastases, identification of patients having a greater chance of certain treatments benefit, real-time monitoring of therapy response and early detection of cancer recurrence. An existing biomarker in oncology is the number of a patient circulating tumor cells (CTC) in the peripheral blood, which have detached from the primary tumor or metastasis. While there are several companies trying to commercialize CTCs detection platforms, the application of this biomarker is not yet widespread in the clinic: there is only one FDA-approved technology, CellSearch® who knows weaknesses in the sensitivity / specificity (since it is limited to recognition of a restricted subtype of cancer cells), the cost per analysis and limitations on further analysis of selected cells (these in fact are not extracted individually, are labeled and not vital). New methods are under development, but our methodology (selection based on cell behavior, ie the cell metabolism) is radically different and has never been explored, giving us the expectation to address the deficiencies of other techniques. Therefore CytoFind objective is to develop a diagnostic device for CTC enumeration and isolation, based on our new patented technology. The proposed method should lead to an overall improvement of the oncology care cycle through improved therapy selection (a reduction in the number of unnecessary treatments) and personalization, monitoring of therapy’s effects (better outcomes, improved quality of life patients and lower costs through a reduction in hospitalizations), and early detection of recurrences.
The objective of this project has been to investigate the economic feasibility of the proposed innovation and the preparation of a business plan to develop a new in vitro diagnostic test in order to detect cancer cells in the blood, help the clinician in the selection of the best therapy and give a rapid and robust feedback to monitor the effectiveness of therapy. The method makes use of the fact that tumor cells exhibit a different metabolism, which makes them secrete significantly higher amounts of lactate (lactic acid) and other acidic products than normal cells. This approach, that is linked to the gold standard for the detection of malignancy in tissues (PET, positron emission tomography), has never taken into account at the single cell level. The proposed technology screens for individual cells in a blood sample and can determine, by measuring the degree of acidity, if a cell is abnormal (tumoral). The cells can then be isolated and extracted for further analysis (such as immunostaining, detection of genetic mutations or DNA-RNA sequencing for the detection of clinically relevant features), thus greatly improving the diagnosis, care and treatment of cancer, which leads to a higher quality of life for the patient, with fewer unnecessary surgeries, personalized diagnosis and treatment, and better understanding of aftercare and development of the disease after treatment. Also, the living tumor cells may be analyzed, which leads to more insight into the stage of the disease, and the development of cancer as a disease in general.
