Molecular Designs announced it has submitted a 510(k) premarket notification for its SimplicityDx Respiratory Panel to the U.S. Food and Drug Administration (FDA). The in vitro diagnostic (IVD) panel is designed for the simultaneous detection of SARS-CoV-2 (COVID-19), Influenza A, Influenza B, and Respiratory Syncytial Virus (RSV).
The panel is a multiplex real-time RT-PCR assay that is designed to detect viral RNA in anterior nasal swabs. It includes two targets for SARS-CoV-2, one each for Influenza A and B, and two for RSV, alongside an internal control to validate run performance.
The panel’s breakaway format is designed to allow labs to use only the tests needed during each run, helping reduce waste, manage inventory more efficiently, and lower costs. This flexibility can be especially valuable for labs facing staffing constraints or unpredictable testing volumes.
With many labs shifting toward multiplex panels to streamline respiratory testing, the SimplicityDx Respiratory Panel has the potential to provide a practical solution for combining multiple assays into a single, efficient workflow. Its format supports batch processing and reduces the need for repeated control runs, helping labs handle larger volumes without adding extra workload.
Read the full announcement here
