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Rapid, robust & scaleable platform technology for fully automated reference laboratory grade Polymerase Chain Reaction (PCR) based diagnostics regardless of global setting

Final Report Summary - RANGER (Rapid, robust & scaleable platform technology for fully automated reference laboratory grade Polymerase Chain Reaction (PCR) based diagnostics regardless of global setting)

Seasonal, or epidemic influenza, has a global incidence of 10-20%, is responsible for between 3 and 5 million cases of severe illness every year resulting in 500,000 deaths annually. Total direct and indirect costs of a severe flu epidemic are estimated at over $12 billion in the US alone. As a consequence, Seasonal Influenza remains one of today's biggest threats to the world's socio-economic health. Rapid, accurate diagnosis of influenza typically requires molecular biological techniques such as the Polymerase Chain reaction (PCR). Although accepted as the gold-standard diagnostic test, PCR remains constrained by its requirement for specialist laboratory staff and high capital equipment costs. As a consequence, PCR is traditionally unsuited to Point-of-Care (PoC) testing and is often beyond the reach of many developing nations which have a recognised need for decentralized disease diagnosis.

The RANGER programme successfully brought together a European consortium of clinical, scientific, engineering and regulatory expertise to develop the first of a new generation of molecular diagnostic systems - the Enigma®ML. From initial concept to a production-ready system in less than three years; the RANGER consortium has proven that with the focussed and collaborative effort of recognised experts, EU framework projects can deliver commercially viable diagnostic products into the global market.

The Enigma®ML is a revolutionary PCR-based diagnostic platform allowing fully-automated, rapid and accurate diagnosis of a wide spectrum of human pathogenic microorganisms in a range of clinical sample types. Under the RANGER programme, the system was developed specifically to provide a PoC molecular test for Seasonal Influenza viruses. Capable of providing laboratory standard Influenza results from a nasal sample in less than 60 minutes, the system requires no specialist operator knowledge, laboratory facilities or ancillary equipment. The system will also allow a more co-ordinated surveillance effort for future outbreaks enabling rapid deployment of resources to control disease spread.

During the three year programme, the consortium successfully delivered production-ready prototype Enigma®ML instruments and ambient-storage consumable cartridges containing all reagents required to perform a fully-automated RT-PCR diagnostic test for Seasonal Influenza A/B. Significant effort was invested in understanding the user requirements, the manufacturability of the system and expectations of the regulated diagnostics markets, the Enigma®ML system was designed from first-principles to meet these all these needs.

The Enigma®ML represents a paradigm shift in molecular diagnostics - for the first time, clinicians and global healthcare professionals will be directly empowered to make timely and informed diagnostic decisions critical to efficient medical intervention and effective patient management in influenza-like illnesses.