TECHNICAL FEASIBILITY
Objective 1: To define and design the plan to develop a block storage system, a block feeder and scanning module that provides images of the block, H&E histology and screen selection of the proper coring areas. Key findings: The block feeding mechanism will be a detachable unit containing places for >100 standard sized histological paraffin tissue blocks, which deliver 300 samples (3 samples from each block) for one micro tissue array. The tissue block feeder will be the interface between the automated tissue archive and the PROMETEO TMA platform. We will design electronic linking (barcode readers) for sample recognition for PROMETEO software.
Objective 2: To define and design the plan to develop a reliable and user independent puncher aligned with the image information. Key findings: We will (1) develop an adaptive needle mechanism, which can modulate the coring force according to the hardness of the Tumour Tissue to be cored (e.g.: Skin very hard - Lung soft), (2) include optical sensors to measure the height of Tissue Blocks (which may have different height and size) and detect punching needles malfunctions during the automatic punching phase.
Objective 3: To define and design the plan to develop a fast pre-scanning, core detection and scanning methods to digitalize the image date all aligned with the clinical information. Key findings: We will develop an automated flow for scanning all donor slides and identifying candidate TMA core regions within the tumour regions. After pathologist confirmation, those regions will be used for TMA production. The development of algorithms to allow tissue identification will provide the basis for the auto manufacturing of TMA blocks.
Objective 4: To define and design the plan to develop an image processing software to automatically analyse single or group of cores for macrostructures, for individual cells and for cytoplasmic, membrane and nuclear staining. Key findings: We will develop new algorithms to interface the PROMETEO TMA platform output (TMA slide xml file with TMA spot barcode and x/y position), which will allow: (1) the TMA slide scanning (developed by ASI); (2) Grid for core matching; (3) dearray algorithm for single core image analysis; (4) Full integration with Quantitative Digital Imaging Analysis Platform (developed by ASI).
Objective 5: To define and design the plan to develop an IVD report form, showing transparency of the entire process starting from core selection to the final clinical diagnoses and the transmission options of the validated results into the LIS system. Key findings: We will develop a Communication Protocol to ensure secure data transfer between the different components of PROMETEO and its users. The function of the Communication Protocol is to transfer the TMA data (unique donor block identifier/bar-code, TMA core geometry/position, etc.) to the ASI scanning system, in order to keep full traceability between donor block and TMA core position. We will also develop different and specific protocols for other commercial scanners (e.g. Aperio, Hamamatsu, etc.) in order to increase the market penetration. We need to develop a communication protocol to provide the user with a full and comprehensive report on the TMA work. The report will include in excel format the geometry of the TMA, the bar-code of the donor block for each core, the image of the donor block and the position where the core was taken and the image of the TMA tissue block.
COMMERCIAL FEASIBILITY
Objective 6: To ensure compliance with EU and FDA regulatory demands on In Vitro diagnostic devices and their approval. Key findings: This task will be performed by DEKRA (a specialized Certification provider) specialized in Medical Equipment CE Mark and IVD Certification. DEKRA will perform the activities of this task as follows: (1) identification of Regulatory and Certification requirements; (2) Electrical Safety Tests according to IEC 1010 for IVD applications; (3) EMC tests according to IVD applications; (4) Certification Report.
Objective 7: To secure PROMETEO’s market viability by confirming it’s expected demand in Europe and US. Key findings: We have conducted a market analysis to confirm the market potential and a favourable horizon for PROMETEO, as has been detailed in page 10 of the report. The global market on In Vitro diagnostic devices is expected to continue growing and is estimated to reach $81,3 billion in 2022. Further results have been detailed on page 11 of the report.
1a.2 Work performed during the reporting period and main results achieved so far
Objective 8: To verify internationalization of PROMETEO. Key findings: We will need to develop PROMETEO’s software and utilities in Multilanguage mode given that there is a global market for our solution.
Objective 9: To assess the public/private health sector particularities within our main EU-target countries. Key findings: We have analyzed the different types of healthcare systems currently in force within the EU and other markets of interest. We have described the health systems used worldwide on page 12 of the report.
Objective 10: To define our exploitation and commercialization strategy. Key findings: Our commercialization strategy relies on sales of fully automatized PROMETEO units (detailed on page 14 of the report).
Objective 11: To secure our distribution by defining alliances with end users in targeted diagnostic and research facilities. Key findings: We will use the International Distribution channels of both companies for the project. With the objective to cover most of the world, and increase the market potential, ISENET and ASI will reinforce their distribution networks, organizing joint sales and service trainings. The activities of this Task will be performed as follows: (1) establishment of International Distribution Network; (2) Organization of Service and Sales Training programs. We will identify key opinion leaders of the sector (pathologists) and engage them in the development, dissemination and validation activities of PROMETEO project.
FINANCIAL FEASIBILITY
Objective 12: To validate our financial projections and growth strategy. Key findings: Our financial projections are described on page 17 of the report.
Objective 13: To validate the price of TMA at EU level and create a business model. Key findings: We have conducted a costs/benefit analysis, which results favourable for PROMETEO (page 16 of the report). We have prepared a business plan supported by the feasibility of the project, displayed in the Commercial and Financial Feasibility sections (starting on page 10 of the report and on until the document end).
Objective 14: To analyse competitors, barriers and opportunities for each selected geographical and application sector. Key findings: The feedback from our partner ASI has contributed to fine-tune our marketing strategy. The analysis of competitors for each sector is detailed on pages 12 and 13 of the report.
Objective 15: To redefine Target Markets, volume of sales, benefits and production capacity. Key findings: We have extended the target market areas to include Asia, Middle East, South America and Africa, given that our partner ASI has extensive distributors in those regions. Our sales will increase significantly if we target more countries.
Objective 16: To evaluate the total investment required for commercializing PROMETEO. Key findings: The total investment needed to complete the project would be close to €3,3M. Detailed description is located in page 20 of the report.
ESTABLISHMENT OF ALLIANCES
Objective 17: To determine if we need any partner to assure the correct manufacturing, testing and dissemination of our platform. Key findings: We have found out that we need a partner with expertise in image analysis and recognition software.
Objective 18: To evaluate the candidates according to their capacities and solvency. Key findings: We have selected Applied Spectral Imaging (ASI), based on their complementary skills for the development of the PROMETEO project.
RISK ASSESSMENT, CONTINGENCY PLAN AND IPR PROTECTION
Objective 19: To define the risks of the project and develop contingency actions. Key findings: We describe the identified risk and the selected contingency measures separated by technical and commercial risks on page 18 of the report.
Objective 20: To perform an in depth FTO analysis to assure the viability of the project and define the IPR protection plan. Key findings: There are no direct competitors for PROMETEO. Our IPR and FTO analyses and strategy is described on page 19 of the report.
