Community Research and Development Information Service - CORDIS

H2020

SOFT Report Summary

Project ID: 791086

Periodic Reporting for period 1 - SOFT (SOFT, the first camera-based colorectal cancer screening test to detect occult blood in faeces immediately and with no lab analysis.)

Reporting period: 2017-11-01 to 2018-02-28

Summary of the context and overall objectives of the project

The ambitious goal set by the Commission Communication on Action Against Cancer is to reduce cancer incidence by 15% by 2020. Our aim is to assist the Commission in achieving this goal for CRC. The same report also outlines, as a major objective, the need for actions to reduce the disparity between the best and worst performing Member States by 70% by 2020. Conservative estimates show that cancer had cost EU Member States €126 billion in 2009, with healthcare expenses accounting for €51 billion (40%). Member State productivity losses were estimated at €42.6 billion and lost working days were estimated at €9.43 billion . Approximately 4.3 percent of men and women will be diagnosed with colorectal cancer (CRC) at some point during their lifetime . Costs can be avoided especially in the case of false positives as these are responsible for causing further unnecessary tests and follow-up visits adding to the patient’s stresses as well as medical complications and expenses. This will help all EU countries, but even more significantly Member States currently falling behind in CRC mass screening programmes

The SOFT solution detects occult blood in faeces accurately and immediately, using a smartphone add-on. The uniqueness of SOFT resides in leveraging an optical tool instead of chemical/biological media (which requires laboratory analysis). This way, SOFT creates a contactless solution which eliminates embarrassment, promotes participation and eliminates human mistakes associated with the handling, storage and delivery of the sample.

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

Between 1st November 2017 and 28th February 2018, SOFT Medical undertook a Phase 1 feasibility study under the SME Instrument to determine the technical and economic viability of our contactless CRC screening SOFT solution. The assessment confirmed the product’s feasibility.

• The quantification of production costs and the selection of components with a target price for prototyping and ultimate cost of goods sold; and the definition of the value chain; including involvement of other organisations for the next stage of development and validation.
• The Phase 1 study ascertained Israel and Europe as the primary entry point for the solution, before quick expansion to the U.S, before addressing the remaining world markets.
• Considering the route to market dual entries of distributor-led and direct etailer distribution, up to ~0.004% of market penetration (~€100M in revenues) for the combined European, North America, and Asian-Pacific segments are projected by the 5th year of commercialisation, equivalent to over 1.9 Million total users engaged.

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)

The solution relies on detection and analysis of the optical signatures of occult blood (blood in faeces invisible to the naked eye) in order to assess the risk of CRC. The unique light absorption and reflection properties of blood are well documented in scientific literature . The SOFT device leverages such uniqueness to provide accurate and immediate results.

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