Periodic Reporting for period 1 - ASAP-MALDI-MS (Advanced Sample Preparation by Electrowetting Technology for MALDI Mass Spectrometry)
Periodo di rendicontazione: 2017-02-01 al 2017-05-31
eMALDI is a unique patented sample preparation technology which solves the critical bottleneck of heterogeneous residue formation in the sample preparation stage by exciting complex fluids throughout the drying process by means of electrowetting (EW). By applying an alternating electric field, eMALDI is able to evaporate part of the liquid from the sample drop and provoke a mass flow in the drop that homogenizes its content, leading to substantially smaller and more homogeneous sample spots on the special electrowetting-functionalized eMALDI target plates. In this way, eMALDI completely suppresses the coffee-stain effect which affects traditional MALDI analysis, enhancing the detection limits by boosting the signal-to-noise ratio up to 150-fold, and also makes the detection process faster (1-2 minutes instead of average 30 minutes) by eliminating the need for time consuming search for spots where the signal is abundant.
The application fields of the eMALDI technology can be innumerable. Nevertheless, we need to invest in the technology development and advance it to a TRL 9 in order to reach a full industrialization of the process and enter new applications (clinical diagnostic) in the European and global market. We need to focus on investigating the technology’s possible deployment, validating its stability in an operational environment, and studying the markets. The main objectives of the Feasibility Study are:
- analyzing the Technical Viability of the eMALDI through an in depth technical analysis of the needed improvements to assure the optimal technological performance;
- studying the Commercial Viability of eMALDI through the quantification of the potential markets, identification of competitors, end-users, manufacturing and distributor partners in selected target areas for commercialization and related strategy to engage them (Communication and Dissemination Plan). We have elaborated a Business Innovation Plan including price and sale strategy (Financial Viability), a draft Commercialization Plan and Work Plan for Phase 2 project implementation.
- analyzing existing patents which can limit our Freedom to Operate (FTO).
We have included 1) risk analysis, identifying the risks which can hamper the project progress and including measures to overcome them; 2) market barrier analysis, describing most relevant factors that may represent challenges or obstacles to a successful market introduction of our eMALDI technology and envisaged mitigation measures.
The application fields of the eMALDI technology can be innumerable. Nevertheless, we need to invest in the technology development and advance it to a TRL 9 in order to reach a full industrialization of the process and enter new applications (clinical diagnostic) in the European and global market. We need to focus on investigating the technology’s possible deployment, validating its stability in an operational environment, and studying the markets. The main objectives of the Feasibility Study are:
- analyzing the Technical Viability of the eMALDI through an in depth technical analysis of the needed improvements to assure the optimal technological performance;
- studying the Commercial Viability of eMALDI through the quantification of the potential markets, identification of competitors, end-users, manufacturing and distributor partners in selected target areas for commercialization and related strategy to engage them (Communication and Dissemination Plan). We have elaborated a Business Innovation Plan including price and sale strategy (Financial Viability), a draft Commercialization Plan and Work Plan for Phase 2 project implementation.
- analyzing existing patents which can limit our Freedom to Operate (FTO).
We have included 1) risk analysis, identifying the risks which can hamper the project progress and including measures to overcome them; 2) market barrier analysis, describing most relevant factors that may represent challenges or obstacles to a successful market introduction of our eMALDI technology and envisaged mitigation measures.
The main conclusion reached through the Feasibility Study is that the project to further develop eMALDI patented evaporation technology to reach commercialization stage should continue as there is clearly a high market demand for the product and little signs of mature market competition up to the present day. Furthermore, the strategic business plan has been reinforced through the positive response from potential customers and relevant stakeholders and interest to participate in the envisaged ASAP-MALDI-MS Phase 2 project (test partners and industry sector already engaged).
Through the Technical Viability Study, we have identified the technical developments that need to be implemented during Phase 2 in order to adapt eMALDI to new application fields, mainly the clinical diagnostic. In the Commercial Feasibility Study, we have analyzed the mass spectrometry market and its growth expectations and segments, narrowing the analysis to the main applications we will be able to target. The increasing demand from the clinical diagnostic and pharmaceutical sector for more advanced, effective and reliable MALDI-TOF techniques represents an enormous opportunity for the market uptake of eMALDI, taking into consideration that the MALDI segment, representing a 10.5% of the value for global MS market, is forecasted to register the highest CAGR (9.3%) in the next years and reach up to €584 million by 2018. Of great importance remains the establishment and review of our supply chain (eMALDI plates and eMALDI-ES suppliers) which will need to be continuously reviewed in order to find the best partners compatible with plans for increased scale operations (as per our Commercialization Plan and evolving Business Innovation Plan and which will be able to meet the growing market demand and applications of our device and a rapid regional expansion. Through the Financial Feasibility Study, we have outlined and demonstrated our sale and price strategy, setting a draft commercialization plan which will initially target final end-users with direct sales and then add distribution partners and agreements to widen our market uptake and reach a more established customer portfolio. We have demonstrated that with the foreseen improvements in the production protocols and costs, we will able to offer a competitive price in the market and reach accumulated profits of €30 million by year 5 post market introduction.
The Feasibility Study results support the need for very careful IPR management both during Phase 2 development and especially following initial commercialization of eMALDI of any new technical development that may arise and need to be regulated.
The Phase 2 product development phase will see eMALDI-BV make final adjustments to our prototype in response to test demonstrations under real-life conditions. During this phase of development, we will benefit from funding to support the cost of implementing the solution and involving potential clients, and then incorporating feedback into the final product. We will also benefit from the SME Instrument Coaching Services to support our expected growth and particularly with respect to the development of distribution agreements with big players of the MS market, ensuring the market penetration. We will also avail ourselves of this service to aid us in understanding specific conditions in the foreign markets (US and Japan) and negotiation with major regulatory authorities.
Through the Technical Viability Study, we have identified the technical developments that need to be implemented during Phase 2 in order to adapt eMALDI to new application fields, mainly the clinical diagnostic. In the Commercial Feasibility Study, we have analyzed the mass spectrometry market and its growth expectations and segments, narrowing the analysis to the main applications we will be able to target. The increasing demand from the clinical diagnostic and pharmaceutical sector for more advanced, effective and reliable MALDI-TOF techniques represents an enormous opportunity for the market uptake of eMALDI, taking into consideration that the MALDI segment, representing a 10.5% of the value for global MS market, is forecasted to register the highest CAGR (9.3%) in the next years and reach up to €584 million by 2018. Of great importance remains the establishment and review of our supply chain (eMALDI plates and eMALDI-ES suppliers) which will need to be continuously reviewed in order to find the best partners compatible with plans for increased scale operations (as per our Commercialization Plan and evolving Business Innovation Plan and which will be able to meet the growing market demand and applications of our device and a rapid regional expansion. Through the Financial Feasibility Study, we have outlined and demonstrated our sale and price strategy, setting a draft commercialization plan which will initially target final end-users with direct sales and then add distribution partners and agreements to widen our market uptake and reach a more established customer portfolio. We have demonstrated that with the foreseen improvements in the production protocols and costs, we will able to offer a competitive price in the market and reach accumulated profits of €30 million by year 5 post market introduction.
The Feasibility Study results support the need for very careful IPR management both during Phase 2 development and especially following initial commercialization of eMALDI of any new technical development that may arise and need to be regulated.
The Phase 2 product development phase will see eMALDI-BV make final adjustments to our prototype in response to test demonstrations under real-life conditions. During this phase of development, we will benefit from funding to support the cost of implementing the solution and involving potential clients, and then incorporating feedback into the final product. We will also benefit from the SME Instrument Coaching Services to support our expected growth and particularly with respect to the development of distribution agreements with big players of the MS market, ensuring the market penetration. We will also avail ourselves of this service to aid us in understanding specific conditions in the foreign markets (US and Japan) and negotiation with major regulatory authorities.
eMALDI provides faster analysis, improved detection sensitivity, easy and fault-free analysis for the popular analytical chemistry technique MALDI. Hence eMALDI brings out the true potential of the leading analysis method MALDI-MS. By improving speed and quantitative comparability eMALDI technology is expected to revolutionize MALDI-based analytical testing and contribute to society’s well-being. eMALDI technology may open up new markets for MALDI-MS and make analytical testing accessible to all levels of social institutions from microbiological pathogen detection, personalized medical testing, food quality testing and assurance.
Compared to existing technologies, eMALDI is providing:
1) Simple, repeatable, fault-free analysis for MALDI technique. Repeatability and consistency of signal is key to all analytical methods. eMALDI eliminates both spatial and sample-to-sample variations in MALDI measurements providing error-free measurements. Where a combinatorial analysis is must (i.e biological samples), error-free repeatable analysis enable users to analyse more samples at lower costs (instrument, user-time, samples)
2) Improved detection sensitivity (up to 150x). By lowering detection limits, eMALDI provides better results with smaller amounts of valuable samples (1 sample is enough compared to 3-5 samples needed in traditional MALDI)
3) Faster detection process: (from 10 – 30 min. to 1-2 min.). eMALDI eliminates the time consuming search of signal-rich “hot spots” saving precious manual user time (cost and energy saving). With more consistent and repeatable results, the total number of measurements needed to get statistically accurate results decreases.
4) Identical sample preparation procedure as MALDI-MS. No extensive training needed for end-users such as lab technicians. Target plates can be used in any MALDI-MS instruments without need of adaptors
5) Versatility. eMALDI can be used in different fields of applications (food and environment safety analysis).
We expect that the benefits of our technology will apply to a wide range of the application areas of standard MALDI-MS. The research fields of application of standard MALDI-MS include pharmaceuticals, biotechnology, industrial chemistry, environmental testing, food & beverage testing, clinical use and academic research. The key application area selected as primary target market for eMALDI is health and biomedical diagnostics, including in particular rapid identification of bacterial microorganism and detection of biomarkers for diseases, two very promising fields, for which mass spectrometry is of already significant and rapidly growing relevance.
eMALDI is a novel diagnostic solution with a very high social and commercial impact. The faster operation analysis, and the better analytical results obtained with eMALDI will benefit MALDI-MS end-users saving up to 57% of costs (instruments, user-time, sample materials) instead of more expensive available techniques. It will also benefit MALDI-MS instrument manufacturers since this improvement will encourage users to buy their equipment. Thanks to the introduction and demonstration of eMALDI into the clinical application, we will also answer to the insufficiencies in current diagnostic practice and contribute to making bacterial infection monitoring economically feasible, faster and more accurate. Clinical effectiveness will be shown in comparisons with established laboratory diagnostic approaches commonly used to detect bacteria and biomarkers.
As for the clinical application of eMALDI, we can evaluate the eMALDI economic benefit by analyzing direct costs (all spending incurred in lab testing, medicines, hospital stays, materials and consumables and staff time) and indirect costs (loss of economic activity during the patient recovery time; insurgence of new infections) which will be drastically reduced thanks to a quicker patient’s infection detection. eMALDI plates can be sold into the market for a price which is very competitive compared to the advanced pre-spotted target plates in the market. Laboratories can drastically reduce their costs by using the eMALDI disposable target plates, since our plates can be used in any MALDI-MS equipment, without needing any additional adjustment nor technical knowledge. In addition to the price advantage, our sample preparation process, by eliminating the 16 hour needed for culturing steps, will reduce the analysis time for positive blood cultures to less than 1 hour from the 24 hours needed in a standard MALDI-MS and can make a very large impact on shortening the time spent in hospital, the resources used in patient care, and a more rapid return to work for working age patients. The principal economic impact for healthcare systems using eMALDI is the reduction in direct costs paid by health services for the patient treatment (cheaper and more efficient technology) and the indirect costs (savings from HCAI infections and shorter hospitalization time).
Furthermore, applicability of eMALDI to a vast number of samples that vary in biological complexity and content will be a solution to different social issues, ranging from drug safety – limiting the adverse drug reaction (ADR)- pharmacovigilance, pharma and biological drug testing, ADA (anti drug antibodies) biomarkers detection (pharmaceutical and biotechnology application), food and water quality, environmental protection (cross borders controls, food and environmental security application).
Compared to existing technologies, eMALDI is providing:
1) Simple, repeatable, fault-free analysis for MALDI technique. Repeatability and consistency of signal is key to all analytical methods. eMALDI eliminates both spatial and sample-to-sample variations in MALDI measurements providing error-free measurements. Where a combinatorial analysis is must (i.e biological samples), error-free repeatable analysis enable users to analyse more samples at lower costs (instrument, user-time, samples)
2) Improved detection sensitivity (up to 150x). By lowering detection limits, eMALDI provides better results with smaller amounts of valuable samples (1 sample is enough compared to 3-5 samples needed in traditional MALDI)
3) Faster detection process: (from 10 – 30 min. to 1-2 min.). eMALDI eliminates the time consuming search of signal-rich “hot spots” saving precious manual user time (cost and energy saving). With more consistent and repeatable results, the total number of measurements needed to get statistically accurate results decreases.
4) Identical sample preparation procedure as MALDI-MS. No extensive training needed for end-users such as lab technicians. Target plates can be used in any MALDI-MS instruments without need of adaptors
5) Versatility. eMALDI can be used in different fields of applications (food and environment safety analysis).
We expect that the benefits of our technology will apply to a wide range of the application areas of standard MALDI-MS. The research fields of application of standard MALDI-MS include pharmaceuticals, biotechnology, industrial chemistry, environmental testing, food & beverage testing, clinical use and academic research. The key application area selected as primary target market for eMALDI is health and biomedical diagnostics, including in particular rapid identification of bacterial microorganism and detection of biomarkers for diseases, two very promising fields, for which mass spectrometry is of already significant and rapidly growing relevance.
eMALDI is a novel diagnostic solution with a very high social and commercial impact. The faster operation analysis, and the better analytical results obtained with eMALDI will benefit MALDI-MS end-users saving up to 57% of costs (instruments, user-time, sample materials) instead of more expensive available techniques. It will also benefit MALDI-MS instrument manufacturers since this improvement will encourage users to buy their equipment. Thanks to the introduction and demonstration of eMALDI into the clinical application, we will also answer to the insufficiencies in current diagnostic practice and contribute to making bacterial infection monitoring economically feasible, faster and more accurate. Clinical effectiveness will be shown in comparisons with established laboratory diagnostic approaches commonly used to detect bacteria and biomarkers.
As for the clinical application of eMALDI, we can evaluate the eMALDI economic benefit by analyzing direct costs (all spending incurred in lab testing, medicines, hospital stays, materials and consumables and staff time) and indirect costs (loss of economic activity during the patient recovery time; insurgence of new infections) which will be drastically reduced thanks to a quicker patient’s infection detection. eMALDI plates can be sold into the market for a price which is very competitive compared to the advanced pre-spotted target plates in the market. Laboratories can drastically reduce their costs by using the eMALDI disposable target plates, since our plates can be used in any MALDI-MS equipment, without needing any additional adjustment nor technical knowledge. In addition to the price advantage, our sample preparation process, by eliminating the 16 hour needed for culturing steps, will reduce the analysis time for positive blood cultures to less than 1 hour from the 24 hours needed in a standard MALDI-MS and can make a very large impact on shortening the time spent in hospital, the resources used in patient care, and a more rapid return to work for working age patients. The principal economic impact for healthcare systems using eMALDI is the reduction in direct costs paid by health services for the patient treatment (cheaper and more efficient technology) and the indirect costs (savings from HCAI infections and shorter hospitalization time).
Furthermore, applicability of eMALDI to a vast number of samples that vary in biological complexity and content will be a solution to different social issues, ranging from drug safety – limiting the adverse drug reaction (ADR)- pharmacovigilance, pharma and biological drug testing, ADA (anti drug antibodies) biomarkers detection (pharmaceutical and biotechnology application), food and water quality, environmental protection (cross borders controls, food and environmental security application).