BIRMINGHAM, Ala., Oct. 2, 2025 -- Molecular Designs, a developer and manufacturer of molecular infectious disease assays, today announced it has submitted a 510(k) premarket notification for its Simplicity™Dx 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).
"Submitting our IVD product to the FDA is an important milestone," said Michael Clark, CEO of Molecular Designs. "It reflects our commitment to giving labs tools that are not only clinically sound, but also practical and efficient to use. Our goal is to help labs streamline testing workflows without sacrificing accuracy or flexibility."
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 Simplicity™Dx 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.
Developed by a physician-led diagnostics team, the panel reflects Molecular Designs' focus on solutions that meet the day-to-day needs of clinical labs. The company is built to move quickly in response to new testing needs and provides labs with personalized support for validation, onboarding, and implementation.
About Molecular Designs
Molecular Designs was founded by physicians looking to simplify delivery of and increase accessibility to cost-effective, streamlined, and easy to use molecular technologies. It offers numerous PCR-based components produced under GMP and ISO 13485:2016 quality standards, as well as complementary reagents and instrumentation. For more information, please visit moleculardesigns.com and follow on LinkedIn.
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