genedrive plc is a molecular diagnostics company developing and commercialising a low cost, rapid, versatile, simple to use and robust point of need molecular diagnostics platform for the diagnosis of infectious diseases and for use in patient stratification (genotyping), pathogen detection and other indications.
Genedrive® is a patented small polymerase chain reaction (PCR) platform which enables rapid nucleic acid amplification and detection from various sample types including plasma, sputum and buccal swabs. With minimal hands on time and single button operation, it provides unambiguous diagnostic results, without the need for specialist knowledge or data interpretation. With no manual calibration or maintenance required, Genedrive® is ideal for low throughput, decentralised laboratories.
Following customer and distributor feedback, genedrive plc sought to enhance its initial version of their Genedrive® HCV ID Kit with connectivity, allowing test data from decentralised settings of use to be remotely sent to patient medical records, treatment and surveillance systems. The design and development of the solution needed to comply with the quality, safety and efficacy requirements for WHO pre-qualification. As the introduction of connectivity to any diagnostic device can vary in scope and cost they required specialist knowledge of the telecommunications domain alongside knowledge of diagnostic development and implementation within intended settings of use.
Connected Diagnostics proposed a high level technical design that would not only allow existing test data captured by the Genedrive® instrument to be sent to remote repositories but that would enable each test result to be supplemented with patient data for identification and treatment purposes. Development of the solution followed ISO13485, ISO14971 and IEC62304 to maintain quality and manage risk.
The project culminated with the launch of the Genedrive® Connect Application, a smartphone companion application that synchronises with the Genedrive® instrument by Bluetooth connection. Genedrive® Connect offers an enhanced operational user interface and ability to remotely send test results to data repositories such as electronic health records and SMS notifications to clinicians for immediate use in time sensitive treatment situations. The project was completed on time, within budget and satisfied all regulatory and quality requirements.
“Our program of work with Connected-Dx has been highly impactful for us, with their unparalleled expertise in real-world low to middle income country diagnostic connectivity solution requirements being invaluable for the successful development of our Genedrive Connect application.”
Director of Research & Development