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New Rapid Multi-Viral Diagnostic Kit Receives CE-IVD Mark

Tue, June 21st 2022

Dragonfly™ detects SARS-CoV-2, Flu A, Flu B, RSV and human rhinovirus without a lab. It is a cost-effective point-of-need portable diagnostic system for infectious disease now commercially available.

New Rapid Multi-Viral Diagnostic Kit Receives CE-IVD Mark

ProtonDx Ltd, an Imperial College health technology spin-out company delivering cost-effective, ultra-rapid, accurate and portable molecular testing, has received CE-IVD marking for its innovative Dragonfly™ in vitro diagnostic system. Dragonfly™ is poised 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 revolutionary 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 proprietary ultra-fast 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, commented: “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 proprietary 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 (IVDD 98/79/EC) which means it is commercially available as an in vitro diagnostic tool in Europe.

About ProtonDx

ProtonDx Ltd was founded in 2020 by Professor Pantelis Georgiou (CEO), Asst Professor Jesus Rodriguez-Manzano (CSO), and Dr Nicolas Moser (CTO), of Imperial College London to deliver ultra-rapid, extremely precise, molecular testing for everyone at the point-of-need to facilitate identification of infectious pathogens worldwide.

Its core technology builds on a decade of innovative research in diagnostics and collaboration between engineering, medicine and molecular biology carried out at Imperial College London by a dedicated multidisciplinary team. ProtonDx team’s ambition is to ensure tests can be conducted quickly, accurately and cost-effectively, wherever and whenever they are needed.

About Dragonfly™

The Dragonfly™ is a <30 minutes sample-to-result in vitro diagnostic test, based on isothermal LAMP technology, intended for the extraction and qualitative detection of SARS-CoV-2 RNA as a single target and combined with the extraction and detection of Influenza A virus, Influenza B virus, human respiratory syncytial virus and human rhinovirus in a multiplex panel from a nasopharyngeal, nasal, throat, and buccal samples. It is intended to aid in triage of COVID-19, influenza type A, influenza type B, RSV and HRV, in samples from people regardless of gender or age, with or without signs and symptoms suggestive of infection. The Dragonfly System consists of hardware, software, and associated panel(s) for detection of specific pathogen(s). A Dragonfly kit contains all materials and accessories required to perform the assay in a self-contained kit that includes, controls, reagents and instructions for use. The Dragonfly is intended for use by an appropriately trained user and is not intended for self-testing.

Dragonfly™ is the first commercially available system from the team at ProtonDx.