Periodic Reporting for period 1 - NO-META (Feasibility study of a NOvel METAbolic liquid biopsy for cancer therapy monitoring)
Periodo di rendicontazione: 2016-08-01 al 2016-12-31
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.
- Technical: determine analytical validity of a prototype, reliability, accuracy, efficacy.
- Economic: define the best market introduction and its economic requirements, identification / quantification of the anticipated benefits, cost / benefit analysis.
- Market: examine competitors, competitive advantage and value proposition. Interviews with users (oncologists) and customers (management of hospitals / wards) have been conducted in several cases.
The new knowledge and insights have been used from this feasibility project to:
- assess the current business model, improve and expand.
- provide more insight into the risks and opportunities of the pre-commercial R & D phase.
- a Go / No Go decision to support to invest in the development and construction of a commercial application based on the technology and the implementation of the business model.
The work ended in the writing of a Business Plan; the business plan also includes an initial regulatory & claims planning in the context of in vitro diagnostics, the requirements necessary for approval and reimbursement, and required clinical studies.
A low cost, large-scalable diagnostic tool in oncology would represent a turning point in the cancer care, giving the best quality of life to patients at lower costs for the society: giving the most appropriate therapeutic approach at the right timing and dosage will improve life of the individual and reduce healthcare spending for society.