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.
