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EPICHECK Report Summary

Project ID: 696425

Periodic Reporting for period 1 - EPICHECK (Detection of Various Cancer Types for Screening and Diagnosis through Blood Samples with Epigenetic Biomarkers Panels)

Reporting period: 2015-10-01 to 2016-03-31

Summary of the context and overall objectives of the project

Nucleix developed a revolutionary platform for the development of Methylation Bio-markers and Bio-Marker panels for screening (early detection of disease) and diagnosis based on epigenetic markers. The platform identifies changes in specific methylation locations of DNA extracted from body fluids such as – urine, blood, stools and sputum. A Bio-Markers panel goal is to distinguish between sick and healthy individuals. The company’s expertise include the identification of the specific loci, comprising a panel of markers that can work in multiplex and generate highly accurate test. Nucleix technology was proven to be extremely sensitive and specific in its first application.
Nucleix focuses initially on the field of cancer detection and screening. Cancer cost the EU €126 billion in 2009, which was 1.07% of EU GDP. 2.45m People in the EU were diagnosed with cancer in 2008, when 1.23 million people in the EU died from cancer in 2008. This is one of the most significant public health issues in the world and in the EU. Nucleix first product, Bladder EpiCheck is a urine test for the detection of Bladder Cancer. It is aimed for monitoring bladder cancer patients as this is a disease with high recurrence rate and requires tight surveillance. This product will be launched in Q3 of 2016. The test is based on a panel of 15 non-overlapping Methylation markers at loci that were identified, developed and owned by the company. This product which has better sensitivity and specificity than any other non-invasive test is a proof of the company’s ability to translate its technology to applicable products.
The company plans to develop EPICHECK - diagnostic kits using multi-loci panel of markers, for the detection and screening of lung cancer and colorectal cancer in blood samples – which is the subject of this applications.

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

We performed several tasks:

Task 1 - Main markets and geographies for product launch, payers policy in the main markets. Result - We collected comprehensive data to decide on first target countries for commercial implementation.
Task 2 - Collaborating with Bio-banks and receiving initial samples. Results - we acquired samples to successfully test our markers.
Task 3 - Find key opinion leaders (KOLs) to get initial feedback for optimal product design and recruit for Clinical Advisory Board. Results - we conducted numerous interviews with KOLs to gather important insights for product development, and we started recruiting for our Clinical Advisory Board.
Task 4 - Mapping of equipment used in clinical labs to direct product development. Result - we now have a priority list for product development and a clear idea about test automation.
Task 5 - Preparing a realistic business plan. Result - we prepared a business plan for this project.

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)

We received very promising results in the early testing of our bio markers with the acquired samples. Once we finish developing such screening tests, it can have a huge health and socioeconomic impact, as both lung cancer and colorectal cancer patients can be drastically benefited from early detection, while today these diseases are detected in a very late stage.

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