Real-time molecular diagnostic testing for human infectious diseases using LAMP (Loop Mediated Isothermal Amplification) technology.

Project Information

HG

Grant agreement ID: 718642

DOI

10.3030/718642

Project closed

EC signature date 12 February 2016

Start date 1 February 2016

End date 31 May 2016

Funded under

• SOCIETAL CHALLENGES - Health, demographic change and well-being

Total cost

€ 71 429,00

EU contribution

€ 50 000,00

Coordinated by

HIBERGENE DIAGNOSTICS LIMITED
Ireland

Periodic Reporting for period 1 - HG (Real-time molecular diagnostic testing for human infectious diseases using LAMP (Loop Mediated Isothermal Amplification) technology.)

Reporting period: 2016-02-01 to 2016-05-31

Summary of the context and overall objectives of the project

In Phase 1, HiberGene assessed the feasibility of launching new molecular diagnostic tests onto the market by addressing both the technical requirements and business opportunity available. The overall objective of the project is to bring 5 different tests for human infectious diseases onto the market by the end of Phase 2 through a successful clinical validation and EU market approval. HiberGene's planned work involves multiplexing their freeze-dried reagents so that a single tube can either test for more than one human infectious disease or remove the need for "control" tests, thereby making them suitable for near-patient settings.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

HiberGene have continued to work closely with the Royal Victoria Hospital Belfast in planning the clinical validation of their new tests. In Phase 1 HiberGene spoke with many hospitals to identify the main requirements to be met for the product to be adopted, particularly main user requirements among small and medium sized hospitals where molecular diagnostic capabilities are limited. They have also engaged with distributors to better understand the market opportunity and potential end users. As of June 2016, agreements have been signed with 11 distributors, covering 37 countries.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

HiberGene are providing the only solution for molecular diagnostic testing that is small, robust, portable and capable of producing rapid results su itable for small/medium sized hospitals and also near-patient settings such as maternity wards. Importantly, it is more affordable than available technologies making the platform accessible to these user groups that otherwise could not obtain molecular diagnostic capabilities in house. The Company leverages a unique combination of licensed patented technology and proprietary in-house IP to deliver a scalable and highly effective range of infectious disease tests which represents a significant progression from the current legacy testing paradigm.

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