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Miniature colon spectral scanner that gives real-time automatic alerts for pathological findings.

Periodic Reporting for period 1 - LEAD (Miniature colon spectral scanner that gives real-time automatic alerts for pathological findings.)

Reporting period: 2018-05-01 to 2018-09-30

The World Health Organization accepts that colorectal cancer (CRC) is a significant health problem that is getting worse: each year approximately 435,000 people are newly diagnosed with CRC and around 50% of these patients die, being CRC the most common newly diagnosed cancer and the second most common cause of cancer deaths in Europe.

Over the last decade, a whole range of technologies have been introduced in clinical practice to screen colorectal cancer. Various non-invasive techniques such as faecal occult blood tests (FOBT) and stool DNA tests (FIT-DNA) exist; however their detection rate is less than 80%. In this context, colonoscopy remains the gold standard for the screening of colorectal cancer. Despite its efficacy and widespread use, it is still an imperfect examination as a high number of missed polyps have been reported (20%-28%). Missed lesions are likely to account for more than half of interval cancers diagnosed at 3 to 5 years after a colonoscopy.

Research has confirmed that the single best prevention for colon cancer is the early detection and removal of all colon polyps: when colorectal cancer is found at an early stage, the 5-year relative survival rate is about 90%. Early detection of CRC will not only lead to a reduction of mortality rate but will also significantly reduce treatment costs. These costs can be avoided especially if the success rates of early polyp detection is improved.

To this end, we have developed LEAD, a cost-effective, disposable miniature colon spectral scanner that drastically improves polyp detection (99% detection rate). Its efficacy has been proved in clinical feasibility studies and the key objectives for its development are now to build a manufacturable device and test its performance in a large EU clinical trial to get the required CE Mark to commercialize it. The SME-I is pivotal in this strategy to de-risk the entire project by accelerating the market entry of this much needed innovation.
We evaluated in detail the current stage of development and given successful results from clinical feasibility studies for the detection of polyps, decided to continue improving the technology to bring a fully commercial product. This study was also instrumental in deriving important product and commercialization developments needed for a successful market launch. The findings have confirmed the key improvements based on customers´needs investigation. Wavelength sensors and processing software will be improved and the entire system will be assembled in a way that it doesn´t affects current practices. During the project, we have also confirmed the implication of key stakeholders in the value chain, assessing their capability to meet large demands. We have analyzed in detail the go-to-market strategy to define the approach for accelerated and effective market uptake.

With promising growth projections and considering the overall results of the Phase 1 assessment, we have concluded that it will be worthwhile to follow-up with the implementation of the development and commercialization plan.
One of the factors potentially accountable for missed lesions during colonoscopy is the relatively narrow field of view (140°-170°) of standard forward viewing (SFV) colonoscopes. In an effort to eliminate this limitation, more sophisticated modalities including advanced technology endoscopes and add-on devices have been developed to address this drawback and maximize colonoscope´s ability to detect potentially culprit polyps, specially aiming to widen the field of view.

Although currently exists solutions to increase polyp detection, they still require special effort from physicians, some are highly expensive and often require special training. Most of them are also based on cameras, so increasing the view also distorts the image quality. Unlike others, LEAD increases the colonoscope view to 360° through its light emitting ring not a camera view – it does not affect the field of view. LEAD automatically detects polyps and acts a safety net for physicians providing an optimum detection solution.

Because most colorectal cancers develop from benign polyps, endoscopic screening, which allows detection and removal of adenomas, will have a larger impact on colorectal cancer incidence and mortality. LEAD would improve the quality of these screening programs by ensuring early polyp detection during colonoscopies – resulting in 1) reduced mortality rates, 2) cost savings, and 3) improved quality of life for ageing population. Its price is competitive enough to disrupt the European colonoscopy market and globally afterwards openning up a new way for polyp screening by delivering superior accuracy compared to conventional treatments.