ProtonDx, an Imperial College health technology spin-out company delivering portable molecular testing, has received CE-IVD marking for its Dragonfly in vitro diagnostic system. The aim of Dragonfly is to help revolutionise rapid infectious disease diagnosis and tracking worldwide.
Dragonfly is a portable, rapid diagnostic system able to identify multiple viral pathogens at the point of need. This approach allows severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A virus (IAV), influenza B virus (IBV), respiratory syncytial virus (RSV) and human rhinovirus (HRV) to be detected in a single test. Using nucleic acid extraction, and isothermal colourimetric detection, the system achieves PCR equivalent sensitivity and specificity in less than 30 minutes from sample to result.
Robert Enck, chairman and president of ProtonDx, said: “We are excited to be delivering an independent infectious disease identification and testing capability for use when confidence, portability, ease-of-use, and immediacy are a real priority. With Dragonfly, we are pleased to offer a proven testing solution that delivers certainty, irrespective of location, in these testing times.”
Dr Jesus Rodriguez-Manzano, co-founder and CSO at ProtonDx, added: “The Dragonfly system has been designed specifically to detect and differentiate multiple pathogens simultaneously with confidence. From a simple respiratory swab with minimal handling, high quality nucleic acids are extracted and provide results equivalent to gold standard laboratory-based PCR, outside of the lab environment at the point-of-need. The Dragonfly system also validates that the sample has been taken and tested correctly to provide added confidence.”
The Dragonfly diagnostic system incorporates the SmartLid sample preparation system to yield high purity DNA and RNA, enabling highly sensitive and accurate pathogen detection. The sample is added to a test panel, incubated, and the result can be captured and stored for traceability by the associated Dragonfly application. Dragonfly is a scalable platform with the flexibility to readily support detection of additional pathogens using the same core technology.
Dragonfly is uniquely suited for infectious disease testing in healthcare settings where portability and quick access to accurate results can support timely treatment decision-making, helping to minimise unnecessary antibiotic use. It is also suitable for use in care homes, the workplace, at sporting and entertainment events, and for travel where testing prior to close contact can avoid disruption and minimise risk to health and wellbeing. The system was successfully employed by Team GB at the 2022 Winter Olympic Games in Beijing, China.
By receiving a CE-IVD Mark, the Dragonfly system complies with the European In-Vitro Diagnostic Devices Directive (IVDD 98/79/EC) which means it is commercially available as an in vitro diagnostic tool in Europe.