NEW YORK – ProtonDx said on Tuesday that it received a CE-IVD mark for its Dragonfly in vitro diagnostic system.
The portable platform supports diagnosis of SARS-CoV-2, influenza A, influenza B, respiratory syncytial virus, and human rhinovirus in a single test. It relies on rapid nucleic acid extraction and isothermal colorimetric detection, and is as sensitive and specific as PCR, the firm said, adding it has a turnaround time of less than 30 minutes.
ProtonDx President Robert Enck said in a statement that Dragonfly delivers to market a "testing capability for use when confidence, portability, ease-of-use, and immediacy are a real priority."
The Dragonfly system also includes ProtonDx's SmartLid sample preparation system, which yields high purity DNA and RNA prior to testing.
The system received a CE-IVD certificate prior to May 26, when the new European In Vitro Diagnostic Regulation began to apply. It was cleared under the previous In Vitro Diagnostic Device, though CE-IVD marks obtained under the IVDD will be valid for several years.
ProtonDx was founded in 2020 to commercialize technology developed by scientists at Imperial College London.