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Feasibility study on Opto-Magnetic Imaging Spectroscopy for cancer screening

Periodic Reporting for period 1 - OMIS (Feasibility study on Opto-Magnetic Imaging Spectroscopy for cancer screening)

Reporting period: 2016-03-01 to 2016-08-31

The cancer challenge is a global challenge, with 8 million deaths and over USD 1 trillion spent per year. The World Health Organisation estimates a 70% increase in cases over the next two decades.
Cancer is a disease that progresses in stages; it is typically diagnosed around Stage 2, by which time symptoms are often present and there is a higher risk the disease is so advanced that the chance of survival is relatively low; the earlier the cancer can be detected, the better for the patient and the lower the cost of treating that patient. Detecting cancer before symptoms become evident is the role of screening.

Several factors are considered when designing screening programmes, among them are the cost of each test to the tax payer, the prevalence of that cancer in the community and the accuracy of those tests. Tumour Trace’s technology aims to significantly reduce the cost of such tests whilst still providing diagnostic grade accuracy, allowing for screening programmes to be more extensive and available for all.

Opto-magnetic Imaging Spectroscopy (OMIS) is a patented technology for detecting cancerous tissue. It analyses light reflected from tissue under examination under different lighting conditions, and compares that light with known values for various stages of cancer. It uses machine learning to develop and improve its ability to detect cancerous tissue, and therefore must be trained.

Our objectives are to:
1. Further improve the accuracy of the OMIS technology;
2. Start multi-site head-to-head clinical trials throughout Europe on Cervical Cancer diagnosis, both fresh tissue and tissue from biobanks;
3. Sell our CE-marked products and services into Europe.
Distribution channels
We have developed more in-depth knowledge about potential routes to distribute our products and services in European countries. We are already working with partners to find the most efficient way of selling into Europe.

Clinical Studies
The Clinical Studies we are undertaking are integral to persuading key opinion leaders and national governments to take up our technology. We have developed a detailed scope of what we hope to achieve with our clinical trials in Europe, and have recruited research organisations to partner with us in this endeavour.

Scaled-up manufacturing
We have designed and built a minimum viable device to demonstrate conformity with the CE marking requirements and to demonstrate to partners and potential customers. We are designing a new version of the device for mass manufacture, and have developed relationships with key suppliers of critical parts to handle the increased complexity of scaled-up manufacturing.

We have undertaken a detailed health-economics study to understand the impact that OMIS would have on Cervical Cancer in the UK; it would save the Health Service around gbp 170,000 (eur 200,000). We have also studied the impacts on countries in mainland Europe, and the number of women going undiagnosed with, or dying from, Cervical Cancer can be reduced significantly by using OMIS.

Regulation and IP Protection
We instructed a firm of patent attorneys to perform a Freedom to Operate assessment, which came back clear. We have developed a clear roadmap of patent filings to complement our product development, and understand the likely implications of the upcoming In-Vitro Diagnositic (IVD) Regulations.

Exploitation and Dissemination
The findings of our work in this feasibility study have been taken in to our revised and improved business plan. We are executing to this plan in order to bring this ground-breaking technology to markets in Europe and elsewhere.
The OMISscan device has been proven to be more accurate and less costly than the current standard cancer screening methods as well as providing the result in a matter of minutes.
Increased accuracy will result in fewer false positive and false negative results, which represent a major problem for current cervical cancer screening tests. This will reduce the number of retests required as well as having a quality-of-life benefit. In the UK, a Cervical Cancer result is posted to the patient tested within 2 weeks of a sample being taken. Having a more accurate result earlier will mean less stress when the result is negative but will also lead to quicker treatment if the result is positive. It has been proven that early diagnosis increases the survival rate as treatment can be provided more quickly.

More accurate testing will also reduce the number of colposcopies performed as it will remove the need for this procedure in those cases where a false positive result would otherwise have been obtained. Again this will lead to financial benefits as well as the personal benefit and stress of having an unnecessary medical procedure.
The OMISscan device has the capability to identify all types of cancer. After Tumour Trace has completed the research and development into other forms of cancer, we will also be able to offer more accurate, less costly and faster results for other cancer types.

Once we have successfully introduced the OMISscan device into the EU, we will introduce testing for other types of cancer as they are developed. The potential benefits from this across all cancers is huge and will offer all EU Member States significant financial and patient benefits in the future.