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Liquid Biopsy blood test in lung cancer diagnosis and monitoring: a next generation noninvasive tumor tracker device

Periodic Reporting for period 1 - CELLETEST (Liquid Biopsy blood test in lung cancer diagnosis and monitoring: a next generation noninvasive tumor tracker device)

Reporting period: 2015-02-02 to 2015-06-01

The ultimate objective of the Celletest project is to develop a next-generation medical device for non-invasive diagnosis and prognosis of metastatic lung cancer. To achieve this ambitious objective, we will exploit the potential of our proprietary technology (patent recently deposited in the Italian Patent Office: VI2014A000214) for the isolation of circulating tumor cells (hereafter referred as CTCs) from the bloodstream. The device will allow the validation of the clinical utility of CTCs, already identified biomarkers in liquid-biopsy of metastatic lung cancers. Before going into details on the Celletest objectives, herein we provide a general overview of the project concept and the business opportunity.
What is a Liquid Biopsy? Liquid biopsy is an emerging and disruptive technology in cancer diagnosis, prognosis and monitoring of evolution of cancer patients under anticancer therapies. This novel technology can be understood as the next generation non-invasive alternative to the current gold standard in cancer diagnosis, tissue biopsy. Tissue biopsy implies an interventional/surgical procedure to sample cells or tissue at the tumor site. The biopsied tissue is examined and analyzed (molecular characterization for the determination of the molecular biomarkers of cancer cells) in order to characterize the cancer cells according to their morphological and biochemical properties. This allows determining the tumor typology and prescribing the most optimal anticancer therapy. Liquid biopsy holds promise as a non-invasive method capable to obtain the same clinically relevant information with just a simple blood extraction.
There are still some unresolved challenges preventing the effective implementation in clinical practice.
Which are these challenges? The main bottleneck in the road towards clinical implementation of liquid biopsy is the isolation of CTCs from the rest of surrounding cells of the bloodstream, highly pure and intact (no damaged or modified). This task is highly challenging from a technical perspective due to their extremely low concentration (1 CTC per billion normal blood cells in cancer patients in an advanced stage) . Some technologies are gently becoming available for CTC isolation, but to date, either the isolated CTC fractions are not pure enough (<80% purity) or if they are highly pure, cells are not intact anymore because the isolation technique implies modifying the cell biology with surface inmunomarkers and strongly influences cell viability limiting further studies on isolated cells and on viability of target CTCs. Therefore, the current technologies for CTC isolation can only be used for the detection and enumeration of CTCs in blood, but not for molecular characterization of the isolated CTCs (if CTCs are not pure or intact their molecular characterization might lead to inconsistent or wrong results). Therefore, in spite of the high potential of CTCs as a liquid biopsy test, currently it is not possible to obtain the same clinically relevant information than with conventional tissue biopsies
There were three major objectives blocks in this feasibility study: technical, commercial and financial feasibility studies. In the same way, the work package for Phase I was structured in three tasks:

• Task 1. Evaluation of the technical feasibility (duration: 2 months). Leader: Ms Barbara Roda
• Task 2. Evaluation of the commercial and financial feasibility (duration: 2 months). Leader: Andrea Zattoni
• Task 3. Preparation of the Business Plan (duration: 1 month). Leader: Mr. Pierluigi Rascagliani

To be consistent with the structure of the planned objectives and activities, our work during these 4 months has been structured as in different sections as follows:
A) Technical feasibility
B) Commercial feasibility
C) Financial feasibility
D) Business Plan
The idea of structuring the deliverable this way, is to provide all the relevant details on the feasibility of the project from different perspectives and based on the outcomes of the feasibility study, present our 5 years business plan dealing with CELLETEST development and commercialization. In each of the four sections mentioned above, we have reported on all the key activities performed during the feasibility study, as planned in the tasks of the work package listed before.
SOCIETAL BENEFITS: Among all cancers, lung cancer is the most common and the leading cause of cancer death for men and women. Celletest will contribute to the society through improving the diagnosis of metastatic lung cancers, so the optimal anticancer therapies can be prescribed. In this way, Celletest holds great potential to reduce the high mortality of lung cancer, being the societal benefits unquestionable. Gender equality will be warranted because patient recruitment will consider 50% men and 50% women.
ECONOMIC BENEFITS: Considering the economic burden of lung cancer amounts for more than €1.88 billion,5 it is obvious that it is a major concern for the sustainability of the healthcare systems worldwide. Celletest will be a more efficient and noninvasive diagnosis tool in addressing this disease. Costs reductions will be achieved in different ways: avoidance of surgical/interventional procedures in tissue biopsies and reduction of costs of ineffective anticancer therapies. It is very difficult to provide an accurate estimation of the costs reductions achievable at this stage (to do so, we have planned a pharmacoeconomic study for this Phase 1), but we consider realistic these costs to be 10% of the total if Celletest is implemented globally in clinical practice, representing more than €100M yearly for the healthcare systems worldwide.
Our strong convincement on the commercial success of the Celletest project relies on our deep knowledge on the current market demands for a solution as the one we intend to develop. We can assertively affirm the market acceptance of the Celletest solution is warranted because we have already validated this issue with some potential clients (hospitals and oncology clinics), which with StemSel is already collaborating. Another proof of the well-sustained market demand for similar solutions is that important big players in the healthcare market, such as Johnson & Johnson (proprietary of the CellSearch® device), are already providing the market with similar (although not so competitive, as explained in section 1.4) solutions. Therefore, for StemSel as a private company, Celletest is strategically understood as the key to boost the company growth in the upcoming years.
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