TETHIS-SBS-CTC: An innovative diagnostic testing platform to identify and characterize circulating tumour cells (CTCs) in blood samples.

Project Information

TETHIS-SBS-CTC

Grant agreement ID: 815529

DOI

10.3030/815529

Project closed

EC signature date 27 April 2018

Start date 1 May 2018

End date 31 August 2018

Funded under

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Total cost

€ 71 429,00

EU contribution

€ 50 000,00

Coordinated by

TETHIS SPA
Italy

Periodic Reporting for period 1 - TETHIS-SBS-CTC (TETHIS-SBS-CTC: An innovative diagnostic testing platform to identify and characterize circulating tumour cells (CTCs) in blood samples.)

Reporting period: 2018-05-01 to 2018-08-31

Summary of the context and overall objectives of the project

There is an urging need for new technology approaches and pharmacological solutions to address the rising incidence of cancer. Current diagnostic options are often difficult to perform and limited in terms of sensitivity and ability to fully capture tumor heterogeneity. Given the drawbacks of the current diagnostic tools, there is a growing enthusiasm for the development of liquid biopsy (LB). LB allows the identification of cells, DNA or other cellular components originating from the tumor from blood and other body fluids. This new, minimally invasive, method for tumor identification shows high diagnostic sensitivity and holds the potential to transform the current cancer managing protocols. Building from a proprietary technology, Tethis has developed a new liquid biopsy platform based on the detection, enumeration, and characterization of circulating tumor cells (CTCs). The following report describes the actions undertaken by Tethis during the SME Instrument Phase I, in which we assessed the market potential of the technology and planned the next phases for the technical and commercial development of the company.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

Phase I has been divided over three tasks: technological feasibility, commercial feasibility, and financial feasibility. The technical feasibility included the identification of the critical points to reach the ready-to-market level of the test, planning of the clinical protocol for a multicentre clinical trial, and contacting three hospitals that will join as subcontractors for the Phase 2. The commercial feasibility analysis included a market analysis that identified and quantified the addressable market according to customers, tumor type and geography, a detailed competitor’s analysis and a review of the IP strategy and Freedom to Operate status. A business plan was built considering the insights from the feasibility study tasks and in line with the commercial strategy. In the financial feasibility we projected revenues and expenses according to the addressable market and Tethis production and testing capacity, resulting in a more accurate assessment of the drivers of profitability of the Tethis services in the upcoming years, as well as the employment projections.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

In Europe alone during the year 2018, more than 12 million persons were living with cancer, accounting for a large fraction of the private and public health expenditure. Late diagnosis of cancers, as well as poor patient management due to the lack of adequate screening methods, is estimated to result in 2-4 times increase of health care costs. The European Code Against Cancer recommends offering effective screening programs to population, in order to reduce morbidity and mortality. Crucial to this point is the ability of diagnostics tests to predict disease status as well as to be amenable to reach a consistent proportion of the target population. Tethis SBS-CTC combines the diagnostic potential of liquid biopsy with an easy to implement workflow and affords a new tool in the fight against cancer. Tethis SBS-CTC will introduce a fast, easy-to-use and affordable device that will massively reduce medical care costs and improve the life quality of cancer patients.

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