Periodic Reporting for period 1 - easierNGS (CERTIFIED PACKS FOR EASIER NEXT-GENERATION SEQUENCING CLINICAL DIAGNOSTICS)
Berichtszeitraum: 2014-10-01 bis 2015-02-28
Next-generation sequencing (NGS) has revolutionized genomic research by drastically decreasing the cost of sequencing and increasing the throughput of generated data, but still has not been able to reach its implementation in clinical diagnostic laboratories where there is a huge potential market application for it. The current market gold-standard in clinical diagnostic (i.e. Sanger-based sequencing) is outdated, much less efficient and more expensive than NGS, but no current market solutions have yet been able to properly address the complexity involved in transferring and validating gold-standard procedures to NGS platforms in clinical environment. In fact, current competing solutions are disruptive, complex, non-efficient and non-validated to address the challenges of transferring NGS to clinics. The easierNGS business concept aims to create and offer an innovative package of services and products which combined will allow a fast, cost-effective, streamlined and certified full sample-to-result solution to clinical laboratories that wish to seize the tremendous benefits of the new NGS era. Towards this objective, STAB VIDA performed a feasibility assessment of the easierNGS business concept, with support from H2020 SME Instrument – Phase 1, to determine its economic, technical and legal viability. A business plan was also prepared defining the most appropriate operational and scheduling strategy to reach the identified target markets, given the overall feasibility of easierNGS.
The work performed during the reporting period, included all aspects described in each of the WP1’s tasks described in the easierNGS DoW. Namely,
- Market analysis
A thorough market analysis regarding clinical NGS was performed. Namely, a specialized market analysis report entitled “NEXT GENERATION SEQUENCING (NGS) MARKET, [Platforms (Illumina HiSeq, MiSeq, HiSeq X Ten, NextSeq 500, Thermo Fisher Ion Proton/PGM), Bioinformatics (Exome Sequencing, RNA-Seq), (SBS, SMRT), (Diagnostics, Personalized Medicine)], GLOBAL FORECAST TO 2020” was purchased from MarketsAndMarkets. A survey related to easierNGS was performed mainly addressing clinical laboratories, but also other key clinical NGS stakeholders (e.g. Hospitals, Universities, etc) and the results were duly analysed. Relevant genetic testing databases were also consulted to create a list of potential clients and identify targets to the easierNGS survey. KOL were contacted to collect their insights on current challenges of clinical NGS and foreseen solutions. And all relevant competitors and potential partners were identified.
- Regulatory issues
All regulatory guidelines and frameworks related to easierNGS business concept have been identified for each of the target markets and its implementation viability was duly assessed. In particular, STAB VIDA consulted the competent national authority, i.e. Infarmed, through a physical meeting, to clarify all regulatory details related to the potential easierNGS manufacturing and sales. Furthermore, the amendments to Directive 98/79/EC about in vitro diagnostic medical devices, which are currently under discussion, have also been thoroughly analysed for risk assessment and future contingency planning.
- IPR strategy study
The IPR issues related to easierNGS business concept were assessed by performing a freedom to operate analysis and consulting with two different patent officers. While, we found that it is not possible to protect the rights of the easierNGS business concept itself, it will be possible to protect the kits through patenting, even though some of its components are already protected by themselves. In this regard, STAB VIDA will be required to license some of the components that will be included in the easierNGS kits, and in this regard, a first approach to their IPR owners has revelled a positive feedback and opening to negotiations. Additionally, the easierNGS trademark was also assessed and is freely available to be registered.
- easierNGS concept design optimization
The overall concept design of the easierNGS business concept was optimized based on the information collected from market study, regulatory and IPR issues and considering its technical/operational viability. In particular, a list of potential components of each easierNGS proof-of-concept kits has been defined and the best bioinformatic solution was identified. Furthermore, the associated costs of each easierNGS component was determined for the three proof-of-concept kits.
- Business plan preparation
After completing all previous described tasks and gathering all relevant economic, technical and legal information, a business plan to implement easierNGS in the identified target markets was defined.
Furthermore, STAB VIDA benefited from the SME Instrument – Phase 1 coaching (3 days). In particular, a German coach (Dr. Norbert Wegerer) and a Spanish coach (Dr. Alejandro Martinez), both with great experience in the healthcare markets of their country, were selected to coach STAB VIDA (for 1.5 day each) on planning the best market approach to the identified target markets (Portugal, Spain, Germany, UK).
In conclusion, a feasibility assessment, including a Business plan with a defined strategy to reach the target markets has been prepared (Deliverable D1.1.) as result of conducting all the previously describe WP1 tasks and coaching. This assessment revealed that easierNGS is feasible and supported a “Go” decision to implement the business concept in the real market.
- Market analysis
A thorough market analysis regarding clinical NGS was performed. Namely, a specialized market analysis report entitled “NEXT GENERATION SEQUENCING (NGS) MARKET, [Platforms (Illumina HiSeq, MiSeq, HiSeq X Ten, NextSeq 500, Thermo Fisher Ion Proton/PGM), Bioinformatics (Exome Sequencing, RNA-Seq), (SBS, SMRT), (Diagnostics, Personalized Medicine)], GLOBAL FORECAST TO 2020” was purchased from MarketsAndMarkets. A survey related to easierNGS was performed mainly addressing clinical laboratories, but also other key clinical NGS stakeholders (e.g. Hospitals, Universities, etc) and the results were duly analysed. Relevant genetic testing databases were also consulted to create a list of potential clients and identify targets to the easierNGS survey. KOL were contacted to collect their insights on current challenges of clinical NGS and foreseen solutions. And all relevant competitors and potential partners were identified.
- Regulatory issues
All regulatory guidelines and frameworks related to easierNGS business concept have been identified for each of the target markets and its implementation viability was duly assessed. In particular, STAB VIDA consulted the competent national authority, i.e. Infarmed, through a physical meeting, to clarify all regulatory details related to the potential easierNGS manufacturing and sales. Furthermore, the amendments to Directive 98/79/EC about in vitro diagnostic medical devices, which are currently under discussion, have also been thoroughly analysed for risk assessment and future contingency planning.
- IPR strategy study
The IPR issues related to easierNGS business concept were assessed by performing a freedom to operate analysis and consulting with two different patent officers. While, we found that it is not possible to protect the rights of the easierNGS business concept itself, it will be possible to protect the kits through patenting, even though some of its components are already protected by themselves. In this regard, STAB VIDA will be required to license some of the components that will be included in the easierNGS kits, and in this regard, a first approach to their IPR owners has revelled a positive feedback and opening to negotiations. Additionally, the easierNGS trademark was also assessed and is freely available to be registered.
- easierNGS concept design optimization
The overall concept design of the easierNGS business concept was optimized based on the information collected from market study, regulatory and IPR issues and considering its technical/operational viability. In particular, a list of potential components of each easierNGS proof-of-concept kits has been defined and the best bioinformatic solution was identified. Furthermore, the associated costs of each easierNGS component was determined for the three proof-of-concept kits.
- Business plan preparation
After completing all previous described tasks and gathering all relevant economic, technical and legal information, a business plan to implement easierNGS in the identified target markets was defined.
Furthermore, STAB VIDA benefited from the SME Instrument – Phase 1 coaching (3 days). In particular, a German coach (Dr. Norbert Wegerer) and a Spanish coach (Dr. Alejandro Martinez), both with great experience in the healthcare markets of their country, were selected to coach STAB VIDA (for 1.5 day each) on planning the best market approach to the identified target markets (Portugal, Spain, Germany, UK).
In conclusion, a feasibility assessment, including a Business plan with a defined strategy to reach the target markets has been prepared (Deliverable D1.1.) as result of conducting all the previously describe WP1 tasks and coaching. This assessment revealed that easierNGS is feasible and supported a “Go” decision to implement the business concept in the real market.
The positive feasibility assessment of easierNGS business concept will be proceeded by the implementation of easierNGS to reach its identified target markets, hopefully with the support of H2020 SME Instrument – Phase 2. The implementation of easierNGS in the clinical diagnostic market should represent a big turnover to the implementation of NGS in clinical environment, with great benefits to the NGS industry, clinical diagnostic labs, medical doctors and patients. The later will be able to ultimately benefit from better diagnostics and a more accessible personalized medicine.
In particular, the easierNGS should greatly contribute to the growth of clinical NGS market in Europe, which currently worth $112.8 Million USD and has an estimated CAGR (2014-2020) of 23.3% - the lowest compared to other world regions (i.e. North America: 24.6%., Asia: 26.8%, RoW: 25.9%).
In particular, the easierNGS should greatly contribute to the growth of clinical NGS market in Europe, which currently worth $112.8 Million USD and has an estimated CAGR (2014-2020) of 23.3% - the lowest compared to other world regions (i.e. North America: 24.6%., Asia: 26.8%, RoW: 25.9%).