#	Pagina
attuale pagina	/open-h2020/projects/194776/results.html

Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - PoC-Cycle (Innovative Molecular Diagnostics point-of-care device for MRSA)

Teaser

Summary

FRIZ Biochem, a privately held company with well-experienced staff, has developed CYCLEÂ®, a unique Molecular Diagnostic (MDx) testing platform suited for Point-of-Care testing. The company is EN ISO 13485:2012 certified for â€œDesign and Development, Production and Distribution, Installation and Service of Nucleic Acid based in-vitro Diagnosticsâ€. While the strategic advantage of CYCLEÂ® Diagnostics arises from the opportunity of combining integrated workflow with multiplex testing suited for a wide range of applications at central labs and the Point of Care, the ultimate success will be driven by the cost proposition of the system. Based on inexpensive CMOS-based sensor technology, the consumables are highly cost-effective. Also the processor for cartridge handling can be manufacured at low cost since the expensive detection unit necessary for commercial fluorescence based technologies can be spared due to FRIZ Biochemâ€™s chip integrated electrical detection technology. Additionally, CYCLEÂ® comprises reduced hands-on-time (1 min.) and lowest turn-around-time for commercially available systems (30 min.) and is the first real closed system with minimised risk of contamination that provides laboratory quality results at the Point of Care.

In a feasibility study conducted within the EU Framework Programme for Research and Innovation (Horizon 2020, SME instruments, Phase 1) main stakeholders were identified and interviewed, FTO-analyses were performed with respect to potential infringements of foreign patents of the complex co-operative technological development and access to all IP, Know-How and marketing rights for those parts developed in cooperation were secured. To proof performance of the technology, initial market entry shall be addressed by a screening test for MRSA , a health care acquired infection with wide spread and growing negative impact to European patients and health care systems. The study resulted in a business plan for the the period from prototype establishment via clinical evaluation study to market entry (TRL 6 to TLR 9) that also includes a first commercialisation strategy for the European market. The planning contains some minor technological adjustments, reveals freedom to operate for all major aspects of the technology, addresses the concept for assembly/production of consumables and related processors as well as conception of the clinical evaluation process. Market access shall be realised by partnering with laboratory service providers in order to avoid market share competition of PoC testing and laboratory testing as well as to use the partnersâ€™ established customer contacts and distribution opportunities.

Work performed

Overview:

FRIZ Biochem, a privately held company with well-experienced staff, founded and managed by Dr. Gerhard Hartwich, developed CYCLEÂ®, a unique Molecular Diagnostic (MDx) testing platform suited for Point-of-Care testing. To proof performance of the technology, initial market entry shall be addressed by a screening test for MRSA , a health care acquired infection with wide spread and growing negative impact to European patients and health care systems. Main objectives of the feasibility study were:
- Identify main stakeholders such as end-users / partners for performance evaluation and distribution
- Undertake a market study adressing also quality of technological concept
- Update a freedom-to-operate report
- Elaborate a business plan

Market opportunities for FRIZ Biochemâ€™s CYCLEÂ® technology were analysed using the stakeholders as sources to analyse market size, market situation, market entry strategy, price policy and marketability of the platform technology for Molecular Diagnostics (MDx, a segment of In Vitro Diagnostics) in general as well as health-care acquired infections like MRSA in particular. Though MRSA screening at the Point-of-Care (PoC) will be the first product launched on basis of CYCLEÂ® technology, it is suited for the widest possible range of applications. The cost proposition of the system facilitates access to about 50% of the current $ 5 billion MDx market. Additionally, it is an enabling technology at emerging growth regions for testing in developing countries where infrastructure and health care situation offer a number of interesting opportunities for PoC systems versus central lab testing.

While the strategic advantage of CYCLEÂ® Diagnostics arises from the opportunity of combining integrated workflow with multiplex testing, suited for the widest possible range of applications for clients at central labs and the Point of Care, the ultimate success will be driven by the cost proposition of the system: based on inexpensive CMOS-based sensor technology, the consumables offer a paradigm shift in the cost structure of MDx technology.

CYCLEÂ® comprises
- significant cost advantage over leading competitive systems
- reduced hands-on time (1 min.)
- lowest turn-around-time for commercially available systems (30 min.)
- first real closed system (highest security / minimum risk of contamination)
- laboratory quality results at the Point of Care

For the feasibility study main stakeholders were identified and interviewed, FTO-analyses were performed with respect to potential infringements of foreign patents of the complex co-operative technological development as well as accessability to all IP, Know-How and marketing rights for those parts developed in cooperation. The study resulted in a business plan for the period from prototype establishment via clinical evaluation study to market entry (TRL 6 to TLR 9) that also includes a first commercialisation strategy for the European market. The planning contains some minor technological adjustments, reveals freedom to operate for all major aspects of the technology, adresses the concept for assembly/production of consumables and related processor as well as details of the clinical evaluation process.

Market entry may be accomplished by any model within the range of external distribution, co-operative partnering with e.g. laboratory service providers or by establishing a sales joint venture as well as an own sales force. For a strategic point of view partnering with laboratory service providers seems highly attractive due to avoiding market share competition of PoC testing and laboratory testing as well as using established customer contact and distribution opportunities of renowned and internationally operating laboratory service providers.

Conclusion of the action:

(i) Action Resources:
Technological readiness, market opportunities, market access, price policy and marketability for FRIZ Biochemâ€™s CYCLEÂ® technology were